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Vitamin D3 in Systemic Lupus Erythematosus

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ClinicalTrials.gov Identifier: NCT00710021
Recruitment Status : Completed
First Posted : July 3, 2008
Results First Posted : April 25, 2014
Last Update Posted : April 26, 2017
Sponsor:
Collaborator:
Autoimmunity Centers of Excellence
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Systemic Lupus Erythematosus
SLE
Lupus
Interventions Drug: Vitamin D3
Drug: Vitamin D3 placebo
Enrollment 57
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Vitamin D3 2000 IU Vitamin D3 4000 IU
Hide Arm/Group Description Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily). Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily). Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
Period Title: Overall Study
Started 19 19 19
Modified Intent-to-Treat (mITT) 19 17 [1] 18 [2]
Completed 18 16 18
Not Completed 1 3 1
Reason Not Completed
Lost to Follow-up             1             0             0
Subject's Decision             0             1             0
Subject misrandomized             0             1             1
Physician Decision             0             1             0
[1]
2 subjects who did not take study drug were excluded from mITT
[2]
1 subject who did not take study drug was excluded from mITT
Arm/Group Title Placebo Vitamin D3 2000 IU Vitamin D3 4000 IU Total
Hide Arm/Group Description Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily). Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily). Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily). Total of all reporting groups
Overall Number of Baseline Participants 19 17 18 54
Hide Baseline Analysis Population Description
Modified Intent-to-Treat
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants 17 participants 18 participants 54 participants
38.7  (12.3) 36.5  (10.9) 38.3  (12.9) 37.9  (11.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 17 participants 18 participants 54 participants
Female
18
  94.7%
17
 100.0%
16
  88.9%
51
  94.4%
Male
1
   5.3%
0
   0.0%
2
  11.1%
3
   5.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 19 participants 17 participants 18 participants 54 participants
19 17 18 54
Years with Systemic Lupus Erythematosus (SLE) at Baseline   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants 17 participants 18 participants 54 participants
10.9  (7.8) 10.0  (7.8) 8.7  (6.0) 9.9  (7.1)
[1]
Measure Description: Years since systemic lupus erythematosus was diagnosed by a physician. This information was obtained by medical history during the Baseline visit.
Number of American College of Rheumatology (ACR) Criteria met at Screening   [1] 
Mean (Standard Deviation)
Unit of measure:  Number of criteria met
Number Analyzed 19 participants 17 participants 18 participants 54 participants
5.4  (1.3) 5.5  (1.1) 5.8  (1.3) 5.6  (1.2)
[1]
Measure Description: The diagnosis of SLE is made using the American College of Rheumatology (ACR) criteria. The presence of 4 or more of the following 11 ACR criteria is diagnostic for lupus and was required to participate in this trial: malar rash, discoid rash, photosensitive skin rash, oral ulcers, nonerosive arthritis, pleuritis/pericarditis, renal disorder, neurologic disorder, hematologic disorder, immunologic disorder, and a positive antinuclear antibody (ANA) test. Reference: Arthritis Rheum 1997; 40(9): 1725.
Modified SELENA-SLEDAI Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Score
Number Analyzed 19 participants 17 participants 18 participants 54 participants
2.9  (1.2) 2.7  (1.2) 2.6  (1.0) 2.7  (1.1)
[1]
Measure Description: The modified Safety of Estrogens in Lupus Erythematosus National Assessment SLE Disease Activity Index (SELENA-SLEDAI) is calculated from 24 individual descriptors; scores may range from 0 (indicates inactive disease) to 105 (the maximum theoretical score). The SELENA-SLEDAI assesses disease activity for 10 days prior to and including the day of assessment. For this study, the SELENA-SLEDAI score was modified to include proteinuria defined by dipstick rather than 24 hour urine. A SELENA-SLEDAI score of 4 or less, indicative of stable disease, was a requirement to enter this study.
1.Primary Outcome
Title Percent of Participants With an IFN Alpha Signature Response at Week 12
Hide Description Presence of an Interferon (IFN) Alpha signature response is defined as: a reduction in expression from baseline (Screening) of at least 50% for 1 of 3 IFN Alpha responsive genes (Ifit1, Ifi44, Mx1) with concurrent expression in the remaining 2 genes at a level not more than 25% above baseline, or a reduction in expression from baseline of at least 25% for 2 of the 3 IFN Alpha responsive genes with concurrent expression in the third gene at a level of no more than 25% above baseline. Gene expression was measured on peripheral blood samples using qRT-PCR. Missing data were considered as response failures during calculation.
Time Frame 0, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat. Although presence of a positive IFN Alpha Signature at the Screening visit was an entry criterion for the study, 8 subjects (4 Placebo, 2 Vitamin D3 2000 IU, 2 Vitamin D3 4000 IU ) who did not have a signature were included in the study.
Arm/Group Title Placebo Vitamin D3 2000 IU Vitamin D3 4000 IU Vitamin D3 2000 and 4000 IU (Pooled )
Hide Arm/Group Description:
Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
Overall Number of Participants Analyzed 19 17 18 35
Measure Type: Number
Unit of Measure: Percent of participants
36.8 23.5 27.8 25.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vitamin D3 2000 and 4000 IU (Pooled )
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.53
Comments The p-value compares the Placebo with the pooled Vitamin D treatment group.
Method Fisher Exact
Comments [Not Specified]
2.Secondary Outcome
Title Percent of Participants With an IFN Alpha Signature Response at Week 6
Hide Description Presence of an Interferon (IFN) Alpha signature response is defined as: a reduction in expression from baseline (Screening) of at least 50% for 1 of 3 IFN Alpha responsive genes (Ifit1, Ifi44, Mx1) with concurrent expression in the remaining 2 genes at a level not more than 25% above baseline, or a reduction in expression from baseline of at least 25% for 2 of the 3 IFN Alpha responsive genes with concurrent expression in the third gene at a level of no more than 25% above baseline. Gene expression was measured on peripheral blood samples using qRT-PCR. Missing data were considered as response failures during calculation.
Time Frame 0, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat. Although presence of a positive IFN Alpha Signature at the Screening visit was an entry criterion for the study, 8 subjects (4 Placebo, 2 Vitamin D3 2000 IU, 2 Vitamin D3 4000 IU ) who did not have a signature were included in the study.
Arm/Group Title Placebo Vitamin D3 2000 IU Vitamin D3 4000 IU Vitamin D3 2000 and 4000 IU (Pooled )
Hide Arm/Group Description:
Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
Overall Number of Participants Analyzed 19 17 18 35
Measure Type: Number
Unit of Measure: Percent of participants
36.8 17.6 5.6 11.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vitamin D3 2000 and 4000 IU (Pooled )
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.038
Comments The p-value compares the Placebo with the pooled Vitamin D treatment group.
Method Fisher Exact
Comments [Not Specified]
3.Secondary Outcome
Title Percent of Participants With IFN Alpha Signature at Week 12
Hide Description An Interferon (IFN) Alpha signature is defined as: expression of Mx1, Ifit1, or Ifi44 at a level greater than or equal to 4 standard deviations above the mean of a set of normal controls, or expression of 2 of the 3 genes at a level greater than or equal to 2 standard deviations above the mean of a set of normal controls. Gene expression was measured on peripheral blood samples using qRT-PCR. Missing data were assumed as signatures during calculation.
Time Frame 0, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat. Although presence of a positive IFN Alpha Signature at the Screening visit was an entry criterion for the study, 8 subjects (4 Placebo, 2 Vitamin D3 2000 IU, 2 Vitamin D3 4000 IU) who did not have a signature were included in the study.
Arm/Group Title Placebo Vitamin D3 2000 IU Vitamin D3 4000 IU Vitamin D3 2000 and 4000 IU (Pooled )
Hide Arm/Group Description:
Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
Overall Number of Participants Analyzed 19 17 18 35
Measure Type: Number
Unit of Measure: Percent of participants
78.9 94.1 100.0 97.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vitamin D3 2000 and 4000 IU (Pooled )
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.047
Comments The p-value compares the Placebo with the pooled Vitamin D treatment group.
Method Fisher Exact
Comments [Not Specified]
4.Secondary Outcome
Title Percent of Participants With IFN Alpha Signature at Week 6
Hide Description An Interferon (IFN) Alpha signature is defined as: expression of Mx1, Ifit1, or Ifi44 at a level greater than or equal to 4 standard deviations above the mean of a set of normal controls, or expression of 2 of the 3 genes at a level greater than or equal to 2 standard deviations above the mean of a set of normal controls. Gene expression was measured on peripheral blood samples using qRT-PCR. Missing data were assumed as signatures during calculation.
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat. Although presence of a positive IFN Alpha Signature at the Screening visit was an entry criterion for the study, 8 subjects (4 Placebo, 2 Vitamin D3 2000 IU, 2 Vitamin D3 4000 IU) who did not have a signature were included in the study.
Arm/Group Title Placebo Vitamin D3 2000 IU Vitamin D3 4000 IU Vitamin D3 2000 and 4000 IU (Pooled )
Hide Arm/Group Description:
Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
Overall Number of Participants Analyzed 19 17 18 35
Measure Type: Number
Unit of Measure: Percent of participants
84.2 94.1 100.0 97.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vitamin D3 2000 and 4000 IU (Pooled )
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.12
Comments The p-value compares the Placebo with the pooled Vitamin D treatment group.
Method Fisher Exact
Comments [Not Specified]
5.Secondary Outcome
Title qRT-PCR Fold Change in Ifit1 Gene Expression From Baseline to Week 12
Hide Description The Ifit1 gene is one of three genes included in the definition of the alpha-interferon signature used for this study. This gene encodes an interferon-induced protein with tetratricopeptide repeats. Quantitative real-time polymerase chain reaction (qRT-PCR) was used to measure gene expression in peripheral blood mononuclear cells obtained by blood draw. Gene expression is quantified as “fold change” relative to normal controls and is computed using a comparative CT (threshold cycle) method. A study hypothesis was that expression of alpha-interferon signature genes would decrease with increasing vitamin D levels. A decrease in gene expression from baseline to Week 12 is represented as a negative value (and vice versa).
Time Frame 0, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat with available data
Arm/Group Title Placebo Vitamin D3 2000 IU Vitamin D3 4000 IU Vitamin D3 2000 and 4000 IU (Pooled )
Hide Arm/Group Description:
Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
Overall Number of Participants Analyzed 15 15 18 33
Mean (Standard Deviation)
Unit of Measure: qRT-PCR fold change
-8.6  (40.5) -2.9  (57.0) 5.2  (33.9) 1.5  (45.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vitamin D3 2000 and 4000 IU (Pooled )
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.31
Comments The p-value compares the Placebo with the pooled Vitamin D treatment group.
Method F-tests derived from the GLM
Comments The test was for the comparison of pooled Vitamin D versus Placebo after adjustment for baseline Ifit1 expression.
6.Secondary Outcome
Title qRT-PCR Fold Change in Ifit1 Gene Expression From Baseline to Week 6
Hide Description The Ifit1 gene is one of three genes included in the definition of the alpha-interferon signature used for this study. It encodes an interferon-induced protein with tetratricopeptide repeats. Quantitative real-time polymerase chain reaction (qRT-PCR) was used to measure gene expression in peripheral blood mononuclear cells obtained by blood draw. Gene expression is quantified as “fold change” relative to normal controls and is computed using a comparative CT (threshold cycle) method. A study hypothesis was that expression of alpha-interferon signature genes would decrease with increasing vitamin D levels. A decrease in gene expression from baseline to Week 6 is represented as a negative value (and vice versa).
Time Frame 0, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat with available data
Arm/Group Title Placebo Vitamin D3 2000 IU Vitamin D3 4000 IU Vitamin D3 2000 and 4000 IU (Pooled )
Hide Arm/Group Description:
Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
Overall Number of Participants Analyzed 16 13 17 30
Mean (Standard Deviation)
Unit of Measure: qRT-PCR fold change
-15.5  (38.0) -11.6  (35.5) 6.3  (18.1) -1.4  (28.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vitamin D3 2000 and 4000 IU (Pooled )
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.019
Comments The p-value compares the Placebo with the pooled Vitamin D treatment group.
Method F-tests derived from the GLM
Comments The test was for the comparison of pooled Vitamin D versus Placebo after adjustment for baseline Ifit1 expression.
7.Secondary Outcome
Title qRT-PCR Fold Change in Ifi44 Gene Expression From Baseline to Week 12
Hide Description The Ifi44 gene is one of three genes included in the definition of the alpha-interferon signature used for this study. It encodes interferon-induced protein 44. Quantitative real-time polymerase chain reaction (qRT-PCR) was used to measure gene expression in peripheral blood mononuclear cells obtained by blood draw. Gene expression is quantified as “fold change” relative to normal controls and is computed using a comparative CT (threshold cycle) method. A study hypothesis was that expression of alpha-interferon signature genes would decrease with increasing vitamin D levels. A decrease in gene expression from baseline to Week 12 is represented as a negative value (and vice versa).
Time Frame 0, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat with available data
Arm/Group Title Placebo Vitamin D3 2000 IU Vitamin D3 4000 IU Vitamin D3 2000 and 4000 IU (Pooled )
Hide Arm/Group Description:
Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
Overall Number of Participants Analyzed 15 15 18 33
Mean (Standard Deviation)
Unit of Measure: qRT-PCR fold change
-2.5  (16.4) -0.3  (9.8) 2.9  (11.7) 1.4  (10.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vitamin D3 2000 and 4000 IU (Pooled )
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.28
Comments The p-value compares the Placebo with the pooled Vitamin D treatment group.
Method F-tests derived from the GLM
Comments The test was for the comparison of pooled Vitamin D versus Placebo after adjustment for baseline Ifi44 expression.
8.Secondary Outcome
Title qRT-PCR Fold Change in Ifi44 Gene Expression From Baseline to Week 6
Hide Description The Ifi44 gene is one of three genes included in the definition of the alpha-interferon signature used for this study. It encodes interferon-induced protein 44. Quantitative real-time polymerase chain reaction (qRT-PCR) was used to measure gene expression in peripheral blood mononuclear cells obtained by blood draw. Gene expression is quantified as “fold change” relative to normal controls and is computed using a comparative CT (threshold cycle) method. A study hypothesis was that expression of alpha-interferon signature genes would decrease with increasing vitamin D levels. A decrease in gene expression from baseline to Week 6 is represented as a negative value (and vice versa).
Time Frame 0, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat with available data
Arm/Group Title Placebo Vitamin D3 2000 IU Vitamin D3 4000 IU Vitamin D3 2000 and 4000 IU (Pooled )
Hide Arm/Group Description:
Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
Overall Number of Participants Analyzed 16 13 17 30
Mean (Standard Deviation)
Unit of Measure: qRT-PCR fold change
-3.9  (12.8) -4.6  (11.0) 4.1  (5.9) 0.3  (9.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vitamin D3 2000 and 4000 IU (Pooled )
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.050
Comments The p-value compares the Placebo with the pooled Vitamin D treatment group.
Method F-tests derived from the GLM
Comments The test was for the comparison of pooled Vitamin D versus Placebo after adjustment for baseline Ifi44 expression.
9.Secondary Outcome
Title qRT-PCR Fold Change in Mx1 Gene Expression From Baseline to Week 12
Hide Description The Mx1 gene is one of three genes included in the definition of the alpha-interferon signature used for this study. It encodes for the homolog of mouse myxovirus (influenza virus) resistance 1 protein. Quantitative real-time polymerase chain reaction (qRT-PCR) was used to measure gene expression in peripheral blood mononuclear cells obtained by blood draw. Gene expression is quantified as “fold change” relative to normal controls and is computed using a comparative CT (threshold cycle) method. A study hypothesis was that expression of alpha-interferon signature genes would decrease with increasing vitamin D levels. A decrease in gene expression from baseline to Week 12 is represented as a negative value (and vice versa).
Time Frame 0, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat with available data
Arm/Group Title Placebo Vitamin D3 2000 IU Vitamin D3 4000 IU Vitamin D3 2000 and 4000 IU (Pooled )
Hide Arm/Group Description:
Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
Overall Number of Participants Analyzed 15 15 18 33
Mean (Standard Deviation)
Unit of Measure: qRT-PCR fold change
-1.6  (14.0) 2.0  (12.5) 4.8  (11.6) 3.5  (11.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vitamin D3 2000 and 4000 IU (Pooled )
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.29
Comments The p-value compares the Placebo with the pooled Vitamin D treatment group.
Method F-tests derived from the GLM
Comments The test was for the comparison of pooled Vitamin D versus Placebo after adjustment for baseline Mx1 expression.
10.Secondary Outcome
Title qRT-PCR Fold Change in Mx1 Gene Expression From Baseline to Week 6
Hide Description The Mx1 gene is one of three genes included in the definition of the alpha-interferon signature used for this study. It encodes for the homolog of mouse myxovirus (influenza virus) resistance 1 protein. Quantitative real-time polymerase chain reaction (qRT-PCR) was used to measure gene expression in peripheral blood mononuclear cells obtained by blood draw. Gene expression is quantified as “fold change” relative to normal controls and is computed using a comparative CT (threshold cycle) method. A study hypothesis was that expression of alpha-interferon signature genes would decrease with increasing vitamin D levels. A decrease in gene expression from baseline to Week 6 is represented as a negative value (and vice versa).
Time Frame 0, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat with available data
Arm/Group Title Placebo Vitamin D3 2000 IU Vitamin D3 4000 IU Vitamin D3 2000 and 4000 IU (Pooled )
Hide Arm/Group Description:
Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
Overall Number of Participants Analyzed 16 13 17 30
Mean (Standard Deviation)
Unit of Measure: qRT-PCR fold change
-4.8  (10.5) 1.4  (19.5) 0.7  (6.7) 1.0  (13.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vitamin D3 2000 and 4000 IU (Pooled )
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.014
Comments The p-value compares the Placebo with the pooled Vitamin D treatment group.
Method F-tests derived from the GLM
Comments The test was for the comparison of pooled Vitamin D versus Placebo after adjustment for baseline Mx1 expression.
11.Secondary Outcome
Title Change in Serum C3 Level From Baseline to Week 12
Hide Description C3 is a blood test that measures the activity of the complement component 3 (C3) protein. The normal C3 range is 75 to 135 mg/dL. Patients with active systemic lupus erythematosus may have a lower-than-normal level of C3. A decrease in C3 level over time may indicate disease activity. An increase in C3 from baseline to Week 12 is represented as a positive value (and vice versa).
Time Frame 0, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat with available data
Arm/Group Title Placebo Vitamin D3 2000 IU Vitamin D3 4000 IU Vitamin D3 2000 and 4000 IU (Pooled )
Hide Arm/Group Description:
Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
Overall Number of Participants Analyzed 18 16 18 34
Mean (Standard Deviation)
Unit of Measure: mg/dL
1.8  (16.1) 0.7  (11.1) 2.9  (11.1) 1.9  (11.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vitamin D3 2000 and 4000 IU (Pooled )
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.96
Comments The p-value compares the Placebo with the pooled Vitamin D treatment group.
Method F-tests derived from the GLM
Comments The test was for the comparison of pooled Vitamin D versus Placebo after adjustment for baseline serum C3 level.
12.Secondary Outcome
Title Change in Serum C3 Level From Baseline to Week 6
Hide Description C3 is a blood test that measures the activity of the complement component 3 (C3) protein. The normal C3 range is 75 to 135 mg/dL. Patients with active systemic lupus erythematosus may have a lower-than-normal level of C3. A decrease in C3 level over time may indicate disease activity. An increase in C3 from baseline to Week 6 is represented as a positive value (and vice versa).
Time Frame 0, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat with available data
Arm/Group Title Placebo Vitamin D3 2000 IU Vitamin D3 4000 IU Vitamin D3 2000 and 4000 IU (Pooled )
Hide Arm/Group Description:
Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
Overall Number of Participants Analyzed 19 15 18 33
Mean (Standard Deviation)
Unit of Measure: mg/dL
3.3  (10.9) 3.8  (11.2) 3.7  (10.3) 3.8  (10.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vitamin D3 2000 and 4000 IU (Pooled )
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.67
Comments The p-value compares the Placebo with the pooled Vitamin D treatment group.
Method F-tests derived from the GLM
Comments The test was for the comparison of pooled Vitamin D versus Placebo after adjustment for baseline serum C3 level.
13.Secondary Outcome
Title Change in Serum C4 Level From Baseline to Week 12
Hide Description C4 is a blood test that measures the activity of the complement component 4 (C4) protein. The normal range for males is 12 to 72 mg/dL and the normal range for females is 13 to 75 mg/dL. Patients with active systemic lupus erythematosus may have a lower-than-normal level of C4. A decrease in C4 level over time may indicate disease activity. An increase in C4 from baseline to Week 12 is represented as a positive value (and vice versa).
Time Frame 0, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat with available data
Arm/Group Title Placebo Vitamin D3 2000 IU Vitamin D3 4000 IU Vitamin D3 2000 and 4000 IU (Pooled )
Hide Arm/Group Description:
Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
Overall Number of Participants Analyzed 18 16 18 34
Mean (Standard Deviation)
Unit of Measure: mg/dL
0.2  (2.5) -0.3  (2.9) 1.9  (4.4) .9  (3.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vitamin D3 2000 and 4000 IU (Pooled )
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.59
Comments The p-value compares the Placebo with the pooled Vitamin D treatment group.
Method F-tests derived from the GLM
Comments The test was for the comparison of pooled Vitamin D versus Placebo after adjustment for baseline serum C4 level.
14.Secondary Outcome
Title Change in Serum C4 Level From Baseline to Week 6
Hide Description Outcome measure description: C4 is a blood test that measures the activity of the complement component 4 (C4) protein. The normal range for males is 12 to 72 mg/dL and the normal range for females is 13 to 75 mg/dL. Patients with active systemic lupus erythematosus may have a lower-than-normal level of C4. A decrease in C4 level over time may indicate disease activity. An increase in C4 from baseline to Week 6 is represented as a positive value (and vice versa).
Time Frame 0, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat with available data
Arm/Group Title Placebo Vitamin D3 2000 IU Vitamin D3 4000 IU Vitamin D3 2000 and 4000 IU (Pooled )
Hide Arm/Group Description:
Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
Overall Number of Participants Analyzed 19 15 18 33
Mean (Standard Deviation)
Unit of Measure: mg/dL
0.3  (3.3) -0.8  (2.7) 0.4  (2.8) -0.2  (2.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vitamin D3 2000 and 4000 IU (Pooled )
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.65
Comments The p-value compares the Placebo with the pooled Vitamin D treatment group.
Method F-tests derived from the GLM
Comments The test was for the comparison of pooled Vitamin D versus Placebo after adjustment for baseline serum C4 level.
15.Secondary Outcome
Title Change in Status for Anti-double-stranded DNA Autoantibody From Baseline to Week 12
Hide Description Patients with systemic lupus erythematosus (SLE) may have autoantibodies (e.g., self against self) to double-stranded DNA. Double-stranded DNA is one of multiple diagnostic tests for SLE and levels may be associated with disease activity. A positive test for autoantibodies to double-stranded DNA is based on the normal range from the local laboratory. Change in status (+ or -) from baseline is evaluated.
Time Frame 0, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat with available data
Arm/Group Title Placebo Vitamin D3 2000 IU Vitamin D3 4000 IU Vitamin D3 2000 and 4000 IU (Pooled )
Hide Arm/Group Description:
Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
Overall Number of Participants Analyzed 17 16 18 34
Measure Type: Number
Unit of Measure: Percent of participants
Positive at Baseline, Positive at Week 12 94.1 100.0 77.8 88.2
Positive at Baseline, Negative at Week 12 0.0 0.0 11.0 6.0
Negative at Baseline, Positive at Week 12 0.0 0.0 5.6 2.9
Negative at Baseline, Negative at Week 12 5.9 0.0 5.6 2.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vitamin D3 2000 and 4000 IU (Pooled )
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.86
Comments The p-value compares the Placebo with the pooled Vitamin D treatment group.
Method Fisher Exact
Comments [Not Specified]
16.Secondary Outcome
Title Change in Status for Anti-double-stranded DNA Autoantibody From Baseline to Week 6
Hide Description Patients with systemic lupus erythematosus (SLE) may have autoantibodies (e.g., self against self) to double-stranded DNA. Double-stranded DNA is one of multiple diagnostic tests for SLE and levels may be associated with disease activity. A positive test for autoantibodies to double-stranded DNA is based on the normal range from the local laboratory. Change in status (+ or -) from baseline is evaluated.
Time Frame 0, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat with available data
Arm/Group Title Placebo Vitamin D3 2000 IU Vitamin D3 4000 IU Vitamin D3 2000 and 4000 IU (Pooled )
Hide Arm/Group Description:
Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
Overall Number of Participants Analyzed 19 16 18 34
Measure Type: Number
Unit of Measure: Percent of participants
Positive at Baseline, Positive at Week 6 94.7 93.7 88.9 91.2
Positive at Baseline, Negative at Week 6 0.0 6.3 0.0 2.9
Negative at Baseline, Positive at Week 6 0.0 0.0 0.0 0.0
Negative at Baseline, Negative at Week 6 5.3 0.0 11.1 5.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vitamin D3 2000 and 4000 IU (Pooled )
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0
Comments The p-value compares the Placebo with the pooled Vitamin D treatment group.
Method Fisher Exact
Comments [Not Specified]
17.Secondary Outcome
Title Change in SELENA-SLEDAI Total Score From Baseline to Week 12
Hide Description The modified Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus (SLE) Disease Activity Index (SELENA-SLEDAI) score is a weighted scale score ranging from 0 to 105 based on the presence or absence of 24 manifestations of SLE. The SELENA-SLEDAI assesses disease activity for 10 days prior to and including the day of assessment. For this study, the SELENA-SLEDAI score was modified to include proteinuria defined by dipstick rather than 24 hour urine. Positive change in the SELENA-SLEDAI score indicate increased disease activity.
Time Frame 0, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat with available data
Arm/Group Title Placebo Vitamin D3 2000 IU Vitamin D3 4000 IU Vitamin D3 2000 and 4000 IU (Pooled )
Hide Arm/Group Description:
Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
Overall Number of Participants Analyzed 18 16 18 34
Mean (Standard Deviation)
Unit of Measure: Change in Scores on a Scale
0.0  (0.7) 0.2  (1.8) 0.2  (1.9) 0.2  (1.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vitamin D3 2000 and 4000 IU (Pooled )
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.62
Comments The p-value compares the Placebo with the pooled Vitamin D treatment group.
Method F-tests derived from the GLM
Comments The test was for the comparison of pooled Vitamin D versus Placebo after adjustment for baseline SELENA-SLEDAI score.
18.Secondary Outcome
Title Cardiorespiratory BILAG Status at Week 12
Hide Description The British Isles Lupus Assessment Group (BILAG) assessment gives a grade for each of 9 body systems (e.g., domains). Grades reflect systemic lupus erythematosus disease activity as follows: A (severe), B (moderate), C (mild), D (inactive at present but previously affected), E (inactive and system never involved). To be randomized, subjects had to have mild or inactive disease (C,D,E) in all but the mucocutaneous system in which B(moderate) disease was also allowed. The percent of subjects experiencing A or B level activity at Week 12 is assessed for the “Cardiorespiratory-specific” body system.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat with available data
Arm/Group Title Placebo Vitamin D3 2000 IU Vitamin D3 4000 IU Vitamin D3 2000 and 4000 IU (Pooled )
Hide Arm/Group Description:
Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
Overall Number of Participants Analyzed 18 16 18 34
Measure Type: Number
Unit of Measure: Percent with grade A or B
0.0 6.3 0.0 2.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vitamin D3 2000 and 4000 IU (Pooled )
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0
Comments The p-value compares the Placebo with the pooled Vitamin D treatment group.
Method Fisher Exact
Comments [Not Specified]
19.Secondary Outcome
Title Constitutional BILAG Status at Week 12
Hide Description The British Isles Lupus Assessment Group (BILAG) assessment gives a grade for each of 9 body systems (e.g., domains). Grades reflect systemic lupus erythematosus disease activity as follows: A (severe), B (moderate), C (mild), D (inactive at present but previously affected), E (inactive and system never involved). To be randomized, subjects had to have mild or inactive disease (C,D,E) in all but the mucocutaneous system in which B(moderate) disease was also allowed. The percent of subjects experiencing A or B level activity at Week 12 is assessed for the “Constitutional-specific” body system.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat with available data
Arm/Group Title Placebo Vitamin D3 2000 IU Vitamin D3 4000 IU Vitamin D3 2000 and 4000 IU (Pooled )
Hide Arm/Group Description:
Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
Overall Number of Participants Analyzed 18 16 18 34
Measure Type: Number
Unit of Measure: Percent with grade A or B
0.0 0.0 0.0 0.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vitamin D3 2000 and 4000 IU (Pooled )
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0
Comments The p-value compares the Placebo with the pooled Vitamin D treatment group.
Method Fisher Exact
Comments [Not Specified]
20.Secondary Outcome
Title Gastrointestinal BILAG Status at Week 12
Hide Description The British Isles Lupus Assessment Group (BILAG) assessment gives a grade for each of 9 body systems (e.g., domains). Grades reflect systemic lupus erythematosus disease activity as follows: A (severe), B (moderate), C (mild), D (inactive at present but previously affected), E (inactive and system never involved). To be randomized, subjects had to have mild or inactive disease (C,D,E) in all but the mucocutaneous system in which B(moderate) disease was also allowed. The percent of subjects experiencing A or B level activity at Week 12 is assessed for the “Gastrointestinal-specific” body system.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat with available data
Arm/Group Title Placebo Vitamin D3 2000 IU Vitamin D3 4000 IU Vitamin D3 2000 and 4000 IU (Pooled )
Hide Arm/Group Description:
Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
Overall Number of Participants Analyzed 18 16 18 34
Measure Type: Number
Unit of Measure: Percent with grade A or B
0.0 0.0 0.0 0.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vitamin D3 2000 and 4000 IU (Pooled )
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0
Comments The p-value compares the Placebo with the pooled Vitamin D treatment group.
Method Fisher Exact
Comments [Not Specified]
21.Secondary Outcome
Title Hematological BILAG Status at Week 12
Hide Description The British Isles Lupus Assessment Group (BILAG) assessment gives a grade for each of 9 body systems (e.g., domains). Grades reflect systemic lupus erythematosus disease activity as follows: A (severe), B (moderate), C (mild), D (inactive at present but previously affected), E (inactive and system never involved). To be randomized, subjects had to have mild or inactive disease (C,D,E) in all but the mucocutaneous system in which B(moderate) disease was also allowed. The percent of subjects experiencing A or B level activity at Week 12 is assessed for the “Hematological-specific” body system.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat with available data
Arm/Group Title Placebo Vitamin D3 2000 IU Vitamin D3 4000 IU Vitamin D3 2000 and 4000 IU (Pooled )
Hide Arm/Group Description:
Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
Overall Number of Participants Analyzed 18 16 18 34
Measure Type: Number
Unit of Measure: Percent with grade A or B
0.0 0.0 0.0 0.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vitamin D3 2000 and 4000 IU (Pooled )
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0
Comments The p-value compares the Placebo with the pooled Vitamin D treatment group.
Method Fisher Exact
Comments [Not Specified]
22.Secondary Outcome
Title Mucocutaneous BILAG Status at Week 12
Hide Description The British Isles Lupus Assessment Group (BILAG) assessment gives a grade for each of 9 body systems (e.g., domains). Grades reflect systemic lupus erythematosus disease activity as follows: A (severe), B (moderate), C (mild), D (inactive at present but previously affected), E (inactive and system never involved). To be randomized, subjects had to have mild or inactive disease (C,D,E) in all but the mucocutaneous system in which B(moderate) disease was also allowed. The percent of subjects experiencing A or B level activity at Week 12 is assessed for the “Mucocutaneous-specific” body system.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat with available data
Arm/Group Title Placebo Vitamin D3 2000 IU Vitamin D3 4000 IU Vitamin D3 2000 and 4000 IU (Pooled )
Hide Arm/Group Description:
Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
Overall Number of Participants Analyzed 18 16 18 34
Measure Type: Number
Unit of Measure: Percent with grade A or B
5.6 12.5 0.0 5.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vitamin D3 2000 and 4000 IU (Pooled )
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0
Comments The p-value compares the Placebo with the pooled Vitamin D treatment group.
Method Fisher Exact
Comments [Not Specified]
23.Secondary Outcome
Title Musculoskeletal BILAG Status at Week 12
Hide Description Outcome measure description: The British Isles Lupus Assessment Group (BILAG) assessment gives a grade for each of 9 body systems (e.g., domains). Grades reflect systemic lupus erythematosus disease activity as follows: A (severe), B (moderate), C (mild), D (inactive at present but previously affected), E (inactive and system never involved). To be randomized, subjects had to have mild or inactive disease (C,D,E) in all but the mucocutaneous system in which B(moderate) disease was also allowed. The percent of subjects experiencing A or B level activity at Week 12 is assessed for the “Musculoskeletal-specific” body system.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat with available data
Arm/Group Title Placebo Vitamin D3 2000 IU Vitamin D3 4000 IU Vitamin D3 2000 and 4000 IU (Pooled )
Hide Arm/Group Description:
Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
Overall Number of Participants Analyzed 18 16 18 34
Measure Type: Number
Unit of Measure: Percent with grade A or B
5.6 0.0 11.1 5.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vitamin D3 2000 and 4000 IU (Pooled )
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0
Comments The p-value compares the Placebo with the pooled Vitamin D treatment group.
Method Fisher Exact
Comments [Not Specified]
24.Secondary Outcome
Title Neuropsychiatric BILAG Status at Week 12
Hide Description The British Isles Lupus Assessment Group (BILAG) assessment gives a grade for each of 9 body systems (e.g., domains). Grades reflect systemic lupus erythematosus disease activity as follows: A (severe), B (moderate), C (mild), D (inactive at present but previously affected), E (inactive and system never involved). To be randomized, subjects had to have mild or inactive disease (C,D,E) in all but the mucocutaneous system in which B(moderate) disease was also allowed. The percent of subjects experiencing A or B level activity at Week 12 is assessed for the “Neuropsychiatric-specific” body system.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat with available data
Arm/Group Title Placebo Vitamin D3 2000 IU Vitamin D3 4000 IU Vitamin D3 2000 and 4000 IU (Pooled )
Hide Arm/Group Description:
Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
Overall Number of Participants Analyzed 18 16 18 34
Measure Type: Number
Unit of Measure: Percent with grade A or B
0.0 0.0 0.0 0.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vitamin D3 2000 and 4000 IU (Pooled )
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0
Comments The p-value compares the Placebo with the pooled Vitamin D treatment group.
Method Fisher Exact
Comments [Not Specified]
25.Secondary Outcome
Title Ophthalmic BILAG Status at Week 12
Hide Description The British Isles Lupus Assessment Group (BILAG) assessment gives a grade for each of 9 body systems (e.g., domains). Grades reflect systemic lupus erythematosus disease activity as follows: A (severe), B (moderate), C (mild), D (inactive at present but previously affected), E (inactive and system never involved). To be randomized, subjects had to have mild or inactive disease (C,D,E) in all but the mucocutaneous system in which B(moderate) disease was also allowed. The percent of subjects experiencing A or B level activity at Week 12 is assessed for the “Ophthalmic-specific” body system.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat with available data
Arm/Group Title Placebo Vitamin D3 2000 IU Vitamin D3 4000 IU Vitamin D3 2000 and 4000 IU (Pooled )
Hide Arm/Group Description:
Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
Overall Number of Participants Analyzed 18 16 18 34
Measure Type: Number
Unit of Measure: Percent with grade A or B
0.0 0.0 0.0 0.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vitamin D3 2000 and 4000 IU (Pooled )
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0
Comments The p-value compares the Placebo with the pooled Vitamin D treatment group.
Method Fisher Exact
Comments [Not Specified]
26.Secondary Outcome
Title Renal BILAG Status at Week 12
Hide Description The British Isles Lupus Assessment Group (BILAG) assessment gives a grade for each of 9 body systems (e.g., domains). Grades reflect systemic lupus erythematosus disease activity as follows: A (severe), B (moderate), C (mild), D (inactive at present but previously affected), E (inactive and system never involved). To be randomized, subjects had to have mild or inactive disease (C,D,E) in all but the mucocutaneous system in which B(moderate) disease was also allowed. The percent of subjects experiencing A or B level activity at Week 12 is assessed for the “Renal-specific” body system.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat with available data
Arm/Group Title Placebo Vitamin D3 2000 IU Vitamin D3 4000 IU Vitamin D3 2000 and 4000 IU (Pooled )
Hide Arm/Group Description:
Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
Overall Number of Participants Analyzed 18 16 18 34
Measure Type: Number
Unit of Measure: Percent with grade A or B
0.0 0.0 0.0 0.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vitamin D3 2000 and 4000 IU (Pooled )
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0
Comments The p-value compares the Placebo with the pooled Vitamin D treatment group.
Method Fisher Exact
Comments [Not Specified]
27.Secondary Outcome
Title Percent of Participants With Adverse Events of Grade 3 or Above
Hide Description Grades are based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0 over the duration of the study. Participants who experienced at least one grade 3 or higher adverse event (AE) are counted only once. The adverse events are treatment-emergent, which means that the AE occurred after taking the first dose of study drug.
Time Frame From start of study treatment through Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety
Arm/Group Title Placebo Vitamin D3 2000 IU Vitamin D3 4000 IU Vitamin D3 2000 and 4000 IU (Pooled )
Hide Arm/Group Description:
Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
Overall Number of Participants Analyzed 19 17 18 35
Measure Type: Number
Unit of Measure: Percent of participants
5.3 23.5 22.2 22.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vitamin D3 2000 and 4000 IU (Pooled )
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.10
Comments The p-value compares the Placebo with the pooled Vitamin D treatment group.
Method Cochran-Mantel-Haenszel
Comments Note that none of the Grade 3 or above events were considered by the investigators to be related to study treatment.
Time Frame Baseline to 12 weeks
Adverse Event Reporting Description This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
 
Arm/Group Title Placebo Vitamin D3 2000 IU Vitamin D3 4000 IU
Hide Arm/Group Description Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily). Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily). Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
All-Cause Mortality
Placebo Vitamin D3 2000 IU Vitamin D3 4000 IU
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Vitamin D3 2000 IU Vitamin D3 4000 IU
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/19 (0.00%)      0/17 (0.00%)      3/18 (16.67%)    
Infections and infestations       
Cellulitis  1  0/19 (0.00%)  0 0/17 (0.00%)  0 1/18 (5.56%)  1
Sinusitis  1  0/19 (0.00%)  0 0/17 (0.00%)  0 1/18 (5.56%)  1
Musculoskeletal and connective tissue disorders       
Systemic lupus erythematosus  1  0/19 (0.00%)  0 0/17 (0.00%)  0 1/18 (5.56%)  1
Nervous system disorders       
Cerebrovascular accident  1  0/19 (0.00%)  0 0/17 (0.00%)  0 1/18 (5.56%)  1
Vascular disorders       
Hypertension  1  0/19 (0.00%)  0 0/17 (0.00%)  0 1/18 (5.56%)  1
Hypertensive emergency  1  0/19 (0.00%)  0 0/17 (0.00%)  0 1/18 (5.56%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Vitamin D3 2000 IU Vitamin D3 4000 IU
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   15/19 (78.95%)      16/17 (94.12%)      15/18 (83.33%)    
Blood and lymphatic system disorders       
Anaemia  1  0/19 (0.00%)  0 3/17 (17.65%)  3 3/18 (16.67%)  3
Lymphopenia  1  2/19 (10.53%)  2 1/17 (5.88%)  1 1/18 (5.56%)  1
Gastrointestinal disorders       
Diarrhoea  1  2/19 (10.53%)  2 0/17 (0.00%)  0 1/18 (5.56%)  1
Infections and infestations       
Upper respiratory tract infection  1  0/19 (0.00%)  0 0/17 (0.00%)  0 4/18 (22.22%)  4
Investigations       
Blood albumin decreased  1  1/19 (5.26%)  1 1/17 (5.88%)  1 1/18 (5.56%)  1
Blood creatinine increased  1  0/19 (0.00%)  0 2/17 (11.76%)  2 1/18 (5.56%)  1
Blood glucose decreased  1  2/19 (10.53%)  2 1/17 (5.88%)  1 0/18 (0.00%)  0
Blood potassium decreased  1  4/19 (21.05%)  4 1/17 (5.88%)  1 1/18 (5.56%)  1
Haemoglobin decreased  1  4/19 (21.05%)  4 3/17 (17.65%)  3 5/18 (27.78%)  5
Lymphocyte count decreased  1  3/19 (15.79%)  3 1/17 (5.88%)  1 2/18 (11.11%)  2
Neutrophil count decreased  1  2/19 (10.53%)  2 3/17 (17.65%)  3 5/18 (27.78%)  5
White blood cell count decreased  1  6/19 (31.58%)  7 2/17 (11.76%)  2 5/18 (27.78%)  5
Metabolism and nutrition disorders       
Hyperglycaemia  1  0/19 (0.00%)  0 2/17 (11.76%)  2 1/18 (5.56%)  1
Hypoalbuminaemia  1  1/19 (5.26%)  1 0/17 (0.00%)  0 3/18 (16.67%)  3
Hypoglycaemia  1  0/19 (0.00%)  0 2/17 (11.76%)  2 2/18 (11.11%)  2
Hypokalaemia  1  0/19 (0.00%)  0 2/17 (11.76%)  2 1/18 (5.56%)  1
Hyponatraemia  1  0/19 (0.00%)  0 2/17 (11.76%)  2 1/18 (5.56%)  1
Musculoskeletal and connective tissue disorders       
Back pain  1  2/19 (10.53%)  2 0/17 (0.00%)  0 1/18 (5.56%)  1
Systemic lupus erythematosus  1  3/19 (15.79%)  3 2/17 (11.76%)  2 1/18 (5.56%)  1
Renal and urinary disorders       
Lupus nephritis  1  1/19 (5.26%)  1 1/17 (5.88%)  1 1/18 (5.56%)  1
Skin and subcutaneous tissue disorders       
Cutaneous lupus erythematosus  1  1/19 (5.26%)  1 1/17 (5.88%)  1 1/18 (5.56%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Director, Clinical Research Operations Program
Organization: DAIT/NIAID
Phone: 301-594-7669
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00710021     History of Changes
Other Study ID Numbers: DAIT ALE02
First Submitted: July 1, 2008
First Posted: July 3, 2008
Results First Submitted: January 9, 2014
Results First Posted: April 25, 2014
Last Update Posted: April 26, 2017