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Analysis of Response of Subjects With Atopic Dermatitis or Psoriasis to Oral Vitamin D3

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ClinicalTrials.gov Identifier: NCT00789880
Recruitment Status : Completed
First Posted : November 13, 2008
Results First Posted : January 22, 2013
Last Update Posted : April 12, 2017
Sponsor:
Collaborator:
Consortium of Food Allergy Research
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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Atopic Dermatitis
Psoriasis
Interventions Drug: Vitamin D3
Drug: Placebo
Enrollment 82
Recruitment Details From January 2009 to November 2009, three centers in the United States recruited participants 18 to 70 years of age who fulfilled eligibility criteria. Refer to the Eligibility section for more details.
Pre-assignment Details  
Arm/Group Title Vitamin D (Non-AD) Vitamin D (AD) Vitamin D (Psoriasis) Placebo (Non-AD) Placebo (AD) Placebo (Psoriasis)
Hide Arm/Group Description Healthy Volunteer participants who did not have atopic dermatitis (Non-AD) and received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 international units [IU] daily). Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily). Participants classified as psoriasis as defined by the ADVN Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily). Healthy Volunteer participants who did not have AD (Non-AD) and received a 21-day course of oral vitamin D3-placebo. Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3- placebo. Participants classified as psoriasis as defined by the ADVN Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3-placebo.
Period Title: Overall Study
Started 16 16 8 16 18 8
Completed 15 15 8 15 15 8
Not Completed 1 1 0 1 3 0
Reason Not Completed
Adverse Event             0             0             0             0             1             0
Protocol Violation             0             1             0             1             0             0
Withdrawal by Subject             1             0             0             0             2             0
Arm/Group Title Vitamin D (Non-AD) Vitamin D (AD) Vitamin D (Psoriasis) Placebo (Non-AD) Placebo (AD) Placebo (Psoriasis) Total
Hide Arm/Group Description Healthy Volunteer participants who did not have atopic dermatitis (Non-AD) and received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 international units [IU] daily). Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily). Participants classified as psoriasis as defined by the ADVN Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily). Healthy Volunteer participants who did not have AD (Non-AD) and received a 21-day course of oral vitamin D3-placebo. Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3- placebo. Participants classified as psoriasis as defined by the ADVN Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3-placebo. Total of all reporting groups
Overall Number of Baseline Participants 16 16 8 16 18 8 82
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants 16 participants 8 participants 16 participants 18 participants 8 participants 82 participants
31.4  (12.3) 32.2  (10.5) 40.5  (11.6) 32.2  (8.9) 28.6  (9.8) 37.1  (11.4) 32.5  (10.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 16 participants 8 participants 16 participants 18 participants 8 participants 82 participants
Female
9
  56.3%
11
  68.8%
4
  50.0%
9
  56.3%
7
  38.9%
4
  50.0%
44
  53.7%
Male
7
  43.8%
5
  31.3%
4
  50.0%
7
  43.8%
11
  61.1%
4
  50.0%
38
  46.3%
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 16 participants 16 participants 8 participants 16 participants 18 participants 8 participants 82 participants
American Indian or Alaska Native 0 0 0 0 0 0 0
Asian 0 4 1 1 2 2 10
Native Hawaiian or Other Pacific Islander 0 0 0 0 0 0 0
Black 2 1 0 2 4 0 9
White 12 9 6 11 11 5 54
More than one race 0 0 0 0 0 0 0
Unknown or Not Reported 0 0 0 0 0 0 0
Other 2 2 1 2 1 1 9
[1]
Measure Description: Race (Reference: Public Health Service [PHS] 398/2590, Revised 6/2009)
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 16 participants 16 participants 8 participants 16 participants 18 participants 8 participants 82 participants
Hispanic or Latino 4 1 1 2 0 1 9
Not Hispanic or Latino 12 15 7 14 18 7 73
Unknown or Not Reported 0 0 0 0 0 0 0
[1]
Measure Description: Ethnicity (Reference: Public Health Service [PHS] 398/2590, Revised 6/2009)
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 16 participants 16 participants 8 participants 16 participants 18 participants 8 participants 82 participants
16 16 8 16 18 8 82
Body Mass Index (BMI; kg/m^2)   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 16 participants 16 participants 8 participants 16 participants 18 participants 8 participants 82 participants
24.6  (5.5) 25.2  (4.7) 28  (6.9) 24.5  (5.0) 24.9  (3.5) 27.1  (4.6) 25.3  (4.9)
[1]
Measure Description:

BMI is a number calculated from a person’s height and weight that provides a reliable indicator of body fatness for most people. Higher values reflect greater amount of body fat. [1] In adults, a BMI less than 18.5 is underweight; 18.5 to 24.9 is a normal or healthy weight; greater than or equal to 25.0 is overweight. The height and weight was collected at baseline only.

[1]: Healthy Weight, Assessing Your Weight, Body Mass Index http://www.cdc.gov/healthyweight/assessing/bmi/index.html

Fitzpatrick Skin Scale   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 16 participants 16 participants 8 participants 16 participants 18 participants 8 participants 82 participants
Extremely Fair Skin 1 1 0 0 1 0 3
Fair Skin 4 2 4 5 3 2 20
Medium Skin 4 5 2 4 7 4 26
Olive Skin 5 7 2 5 2 1 22
Moderately Brown Skin 0 0 0 0 3 1 4
Markedly Black Skin 2 1 0 2 1 0 6
Unknown 0 0 0 0 1 0 1
[1]
Measure Description: This scale classifies skin type categorically based on an individual's genetic disposition and skin’s response to sun exposure.
Serum Vitamin D 25-Hydroxy (ng/mL)   [1] 
Mean (Standard Deviation)
Unit of measure:  ng/mL
Number Analyzed 16 participants 16 participants 8 participants 16 participants 18 participants 8 participants 82 participants
28.8  (13.9) 27.9  (9.7) 31.3  (8.5) 30.4  (11.2) 29.3  (12.2) 28.3  (10.7) 29.2  (11.2)
[1]
Measure Description: Measurement of the amount of Vitamin D in the blood. The normal range used for our study is between 20 and 80 ng/mL.
Serum Creatinine (mg/dL)   [1] 
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 16 participants 16 participants 8 participants 16 participants 18 participants 8 participants 82 participants
0.8  (0.1) 0.8  (0.1) 0.8  (0.2) 0.8  (0.2) 0.8  (0.2) 0.8  (0.1) 0.8  (0.2)
[1]
Measure Description: Creatinine level in the blood is used as a measurement of kidney function. The normal range used for our study is 0.4 to 1.2 mg/dL.
Serum Parathyroid Hormone (pg/mL)   [1] 
Mean (Standard Deviation)
Unit of measure:  pg/mL
Number Analyzed 16 participants 16 participants 8 participants 16 participants 18 participants 8 participants 82 participants
37.2  (11.8) 37.8  (13.7) 27.6  (7.2) 31.4  (11.8) 34.2  (8.6) 35.6  (12.6) 34.4  (11.4)
[1]
Measure Description: Serum Parathyroid hormone level in the blood is a measure of parathyroid gland function. The normal range used for our study is between 15 and 75 pg/mL.
Serum Calcium (mg/dL)   [1] 
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 16 participants 16 participants 8 participants 16 participants 18 participants 8 participants 82 participants
9.3  (0.3) 9.4  (0.4) 9.4  (0.4) 9.3  (0.4) 9.5  (0.3) 9.2  (0.3) 9.4  (0.4)
[1]
Measure Description: Measurement of the amount of calcium in the blood. The normal range used for our study is between 8.4 and 10.2 mg/dL.
Total Serum Immunoglobulin E (IgE)   [1] 
Mean (Standard Deviation)
Unit of measure:  kU/L
Number Analyzed 16 participants 16 participants 8 participants 16 participants 18 participants 8 participants 82 participants
68.4  (127.3) 1870.1  (3310.5) 85.1  (82.0) 45.7  (58.8) 724.9  (2030.6) 69.7  (109.0) 553.3  (1825.2)
[1]
Measure Description: Total amount of IgE in the blood, which is a measurement of allergen sensitization. Higher IgE is indicative of greater allergen sensitization. There is no “normal” level for total serum IgE since a wide overlap exists between the total serum IgE in healthy non-allergic and allergic individuals.
1.Primary Outcome
Title Change From Baseline on Day 21 in Relative Abundance of CAMP mRNA in Lesional and Non-Lesional Skin for Atopic Dermatitis (AD) Participants Who Received Oral Vitamin D3 Versus Vitamin D3-Placebo
Hide Description Cathelicidin (CAMP) Messenger Ribonucleic Acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = [(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)]. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. Cathelicidin amount is clinically significant as it is necessary to resist infection. Cathelicidin amount is not known to be clinically relevant to the clinical signs of dermatitis associated with AD.
Time Frame Baseline to Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vitamin D (AD) Placebo (AD)
Hide Arm/Group Description:
Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3- placebo.
Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: Cycle Number
Lesional Skin Type -0.4  (2.8) 0.1  (2.4)
Non-Lesional Skin Type -0.6  (2.0) 0.7  (2.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vitamin D (AD), Placebo (AD)
Comments Testing whether the change in CAMP expression in lesional skin of AD participants differs by treatment group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7
Comments [Not Specified]
Method ANOVA
Comments P-value is not adjusted for multiple comparisons.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Vitamin D (AD), Placebo (AD)
Comments Testing whether the change in CAMP mRNA expression in non-lesional skin of AD participants differs by treatment group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.12
Comments [Not Specified]
Method ANOVA
Comments P-value is not adjusted for multiple comparisons.
2.Primary Outcome
Title Change From Baseline on Day 21 in Relative Abundance of CAMP mRNA in Non-Lesional Skin for Non-Atopic Dermatitis (Non-AD) Participants Who Received Oral Vitamin D3 Versus Vitamin D3-Placebo
Hide Description Cathelicidin (CAMP) Messenger Ribonucleic Acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = [(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)]. Non-AD is defined as a healthy volunteer without atopic dermatitis, therefore the lesional skin-type was not measured in this group. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. Cathelicidin amount is clinically significant as it is necessary to resist infection. Cathelicidin amount is not known to be clinically relevant to the clinical signs of dermatitis associated with AD.
Time Frame Baseline to Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vitamin D (Non-AD) Placebo (Non-AD)
Hide Arm/Group Description:
Healthy Volunteer participants who did not have atopic dermatitis (Non-AD) and received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 international units [IU] daily).
Healthy Volunteer participants who did not have AD (Non-AD) and received a 21-day course of oral vitamin D3-placebo.
Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: Cycle Number
1.2  (2.4) 0.3  (1.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vitamin D (Non-AD), Placebo (Non-AD)
Comments Testing whether the change in CAMP mRNA expression in non-lesional skin of Non-AD participants differs by treatment group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3
Comments [Not Specified]
Method ANOVA
Comments P-value is not adjusted for multiple comparisons.
3.Primary Outcome
Title Change From Baseline on Day 21 in Relative Abundance of CAMP mRNA in Lesional and Non-Lesional Skin for Psoriatic Participants Who Received Vitamin D3 Versus Vitamin D3-Placebo
Hide Description Cathelicidin (CAMP) messenger ribonucleic acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = [(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)]. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline, Cathelicidin abundance in psoriasis has been hypothesized to correlate with increased inflammation. No direct clinical correlation is known.
Time Frame Baseline to Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vitamin D (Psoriasis) Placebo (Psoriasis)
Hide Arm/Group Description:
Participants classified as psoriasis as defined by the ADVN Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
Participants classified as psoriasis as defined by the ADVN Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3-placebo.
Overall Number of Participants Analyzed 8 8
Mean (Standard Deviation)
Unit of Measure: Cycle Number
Lesional Skin Type -0.9  (3.0) 0.2  (3.2)
Non-Lesional Skin Type -0.6  (2.3) 0.7  (2.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vitamin D (Psoriasis), Placebo (Psoriasis)
Comments Testing whether change in CAMP mRNA expression in lesional skin of psoriatic participants differs by treatment group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4
Comments [Not Specified]
Method ANOVA
Comments P-value is not adjusted for multiple comparisons.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Vitamin D (Psoriasis), Placebo (Psoriasis)
Comments Testing whether change in CAMP mRNA expression in non-lesional skin of psoriatic participants differs by treatment group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2
Comments [Not Specified]
Method ANOVA
Comments P-value is not adjusted for multiple comparisons.
4.Primary Outcome
Title Change From Baseline on Day 21 in Relative Abundance of HBD-3 mRNA in Lesional and Non-Lesional Skin for Atopic Dermatitis (AD) Participants Who Received Oral Vitamin D3 Versus Vitamin D3-Placebo
Hide Description Human Beta-defensin 3 (HBD-3) Messenger Ribonucleic Acid (mRNA) expression from skin biopsies as measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = [(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)]. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. HBD-3 amount is clinically significant as it is necessary to resist infection. HBD-3 amount is not known to be clinically relevant to the clinical signs of dermatitis associated with AD.
Time Frame Baseline to Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vitamin D (AD) Placebo (AD)
Hide Arm/Group Description:
Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3- placebo.
Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: Cycle Number
Lesional Skin Type -0.1  (7.3) -0.8  (2.8)
Non-Lesional Skin Type -0.1  (3.5) 1.4  (3.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vitamin D (AD), Placebo (AD)
Comments Testing whether change in HBD-3 mRNA expression in lesional skin of AD participants differs by treatment group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8
Comments [Not Specified]
Method ANOVA
Comments P-value is not adjusted for multiple comparisons.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Vitamin D (AD), Placebo (AD)
Comments Testing whether change in HBD-3 mRNA expression in non-lesional skin of AD participants differs by treatment group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2
Comments [Not Specified]
Method ANOVA
Comments P-value is not adjusted for multiple comparisons.
5.Primary Outcome
Title Change From Baseline on Day 21 in Relative Abundance of HBD-3 mRNA in Non-Lesional Skin for Non-Atopic Dermatitis (Non-AD) Participants Who Received Oral Vitamin D3 Versus Vitamin D3-Placebo
Hide Description Human Beta-defensin 3 (HBD-3) Messenger Ribonucleic Acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = [(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)]. Non-AD is defined as a healthy volunteer without atopic dermatitis, therefore the lesional skin-type was not measured in this group. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. HBD-3 amount is clinically significant as it is necessary to resist infection. HBD-3 amount is not known to be clinically relevant to the clinical signs of dermatitis associated with AD.
Time Frame Baseline to Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vitamin D (Non-AD) Placebo (Non-AD)
Hide Arm/Group Description:
Healthy Volunteer participants who did not have atopic dermatitis (Non-AD) and received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 international units [IU] daily).
Healthy Volunteer participants who did not have AD (Non-AD) and received a 21-day course of oral vitamin D3-placebo.
Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: Cycle Number
0.2  (2.8) 1.2  (3.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vitamin D (Non-AD), Placebo (Non-AD)
Comments Testing whether change in HBD-3 mRNA expression in non-lesional skin of Non-AD participants differs by treatment group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4
Comments P-value is not adjusted for multiple comparisons.
Method ANOVA
Comments [Not Specified]
6.Primary Outcome
Title Change From Baseline on Day 21 in Relative Abundance of HBD-3 mRNA in Lesional and Non-Lesional Skin for Psoriatic Participants Who Received Vitamin D3 Versus Vitamin D3-Placebo
Hide Description Human Beta-defensin 3 (HBD-3) Messenger Ribonucleic acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = [(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)]. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. There is no known clinical correlation between HBD-3 and psoriasis.
Time Frame Baseline to Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vitamin D (Psoriasis) Placebo (Psoriasis)
Hide Arm/Group Description:
Participants classified as psoriasis as defined by the ADVN Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
Participants classified as psoriasis as defined by the ADVN Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3-placebo.
Overall Number of Participants Analyzed 8 8
Mean (Standard Deviation)
Unit of Measure: Cycle Number
Lesional Skin Type 0.8  (5.3) -1.6  (4.4)
Non-Lesional Skin Type -1.5  (3.2) -1.5  (4.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vitamin D (Psoriasis), Placebo (Psoriasis)
Comments Testing whether change in HBD-3 mRNA expression in lesional skin of psoriatic participants differs by treatment group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4
Comments P-value is not adjusted for multiple comparisons.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Vitamin D (Psoriasis), Placebo (Psoriasis)
Comments Testing whether change in HBD-3 mRNA expression in non-lesional skin of psoriatic participants differs by treatment group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0
Comments P-value is not adjusted for multiple comparisons.
Method ANOVA
Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline on Day 21 in Relative Abundance of IL-13 mRNA in Lesional and Non-Lesional Skin for Atopic Dermatitis (AD) Participants Who Received Vitamin D3 Versus Vitamin D3-Placebo
Hide Description Cytokine interleukin-13 (IL-13) Messenger Ribonucleic Acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = [(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)]. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. A decrease in IL-13 may be clinically correlated with improvement of AD.
Time Frame Baseline to Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vitamin D (AD) Placebo (AD)
Hide Arm/Group Description:
Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3- placebo.
Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: Cycle Number
Lesional Skin Type -0.7  (2.8) 1.1  (2.7)
Non-Lesional Skin Type -0.8  (2.3) -0.1  (3.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vitamin D (AD), Placebo (AD)
Comments Testing whether change in IL-13 mRNA expression in lesional skin of AD participants differs by treatment group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2
Comments P-value is not adjusted for multiple comparisons.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Vitamin D (AD), Placebo (AD)
Comments Testing whether change in IL-13 mRNA expression in non-lesional skin of AD participants differs by treatment group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5
Comments P-value is not adjusted for multiple comparisons.
Method ANOVA
Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline on Day 21 in Relative Abundance of IL-13 mRNA in Non-Lesional Skin for Non-Atopic Dermatitis (Non-AD) Participants Who Received Vitamin D3 Versus Vitamin D3-Placebo
Hide Description Cytokine interleukin-13 ( IL-13) Messenger Ribonucleic Acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = [(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)]. Non-AD is defined as a healthy volunteer without atopic dermatitis. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. A decrease in IL-13 may be clinically correlated with improvement of AD.
Time Frame Baseline to Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vitamin D (Non-AD) Placebo (Non-AD)
Hide Arm/Group Description:
Healthy Volunteer participants who did not have atopic dermatitis (Non-AD) and received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 international units [IU] daily).
Healthy Volunteer participants who did not have AD (Non-AD) and received a 21-day course of oral vitamin D3-placebo.
Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: Cycle Number
0.2  (2.4) 0.5  (1.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vitamin D (Non-AD), Placebo (Non-AD)
Comments Testing whether change in IL-13 mRNA expression in non-lesional skin of Non-AD participants differs by treatment group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7
Comments P-value is not adjusted for multiple comparisons.
Method ANOVA
Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline on Day 21 in Relative Abundance of IL-13 mRNA in Lesional and Non-Lesional Skin for Psoriatic Participants Who Received Vitamin D3 Versus Vitamin D3-Placebo
Hide Description Cytokine interleukin-13 ( IL-13) Messenger Ribonucleic Acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = [(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)]. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. There is no known clinical correlation between IL-13 and psoriasis.
Time Frame Baseline to Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vitamin D (Psoriasis) Placebo (Psoriasis)
Hide Arm/Group Description:
Participants classified as psoriasis as defined by the ADVN Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
Participants classified as psoriasis as defined by the ADVN Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3-placebo.
Overall Number of Participants Analyzed 8 8
Mean (Standard Deviation)
Unit of Measure: Cycle Number
Lesional Skin Type -2.1  (4.6) -0.1  (4.1)
Non-Lesional Skin Type -0.3  (2.7) 0.9  (3.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vitamin D (Psoriasis), Placebo (Psoriasis)
Comments Testing whether change in IL-13 mRNA expression in lesional skin of psoriatic participants differs by treatment group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2
Comments P-value is not adjusted for multiple comparisons.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Vitamin D (Psoriasis), Placebo (Psoriasis)
Comments Testing whether change in IL-13 mRNA expression in non-lesional skin of psoriatic participants differs by treatment group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3
Comments P-value is not adjusted for multiple comparisons.
Method ANOVA
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description There were no serious adverse events. No adverse events occurred at a 5% or greater frequency threshold.
 
Arm/Group Title Vitamin D (Non-AD) Vitamin D (AD) Vitamin D (Psoriasis) Placebo (Non-AD) Placebo (AD) Placebo (Psoriasis)
Hide Arm/Group Description Healthy Volunteer participants who did not have atopic dermatitis (Non-AD) and received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 international units [IU] daily). Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily). Participants classified as psoriasis as defined by the ADVN Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily). Healthy Volunteer participants who did not have AD (Non-AD) and received a 21-day course of oral vitamin D3-placebo. Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3- placebo. Participants classified as psoriasis as defined by the ADVN Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3-placebo.
All-Cause Mortality
Vitamin D (Non-AD) Vitamin D (AD) Vitamin D (Psoriasis) Placebo (Non-AD) Placebo (AD) Placebo (Psoriasis)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Vitamin D (Non-AD) Vitamin D (AD) Vitamin D (Psoriasis) Placebo (Non-AD) Placebo (AD) Placebo (Psoriasis)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/16 (0.00%)   0/8 (0.00%)   0/16 (0.00%)   0/18 (0.00%)   0/8 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Vitamin D (Non-AD) Vitamin D (AD) Vitamin D (Psoriasis) Placebo (Non-AD) Placebo (AD) Placebo (Psoriasis)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/16 (0.00%)   0/8 (0.00%)   0/16 (0.00%)   0/18 (0.00%)   0/8 (0.00%) 
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: NCT00789880     History of Changes
Obsolete Identifiers: NCT01078259
Other Study ID Numbers: DAIT ADVN CATH 03
DAIT-ADVN-CATH-03-01 Sub-study ( Other Identifier: DAIT, NIAID )
First Submitted: November 11, 2008
First Posted: November 13, 2008
Results First Submitted: December 7, 2012
Results First Posted: January 22, 2013
Last Update Posted: April 12, 2017