We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Vitamin D Supplementation in Multiple Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01490502
Recruitment Status : Completed
First Posted : December 13, 2011
Results First Posted : September 28, 2022
Last Update Posted : September 28, 2022
Sponsor:
Collaborators:
Oregon Health and Science University
University of California, San Francisco
Washington University School of Medicine
Icahn School of Medicine at Mount Sinai
University of Pennsylvania
Yale University
The Cleveland Clinic
University of Rochester
Stanford University
University of Virginia
Swedish Medical Center
Anne Arundel Health System Research Institute
Columbia University
University of Massachusetts, Worcester
Dignity Health
Information provided by (Responsible Party):
Johns Hopkins University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Relapsing Remitting Multiple Sclerosis
Intervention Drug: Vitamin D3
Enrollment 172
Recruitment Details Recruitment took place from March 2012 through April 2019 at 16 neurology clinics in the United States.
Pre-assignment Details After successful screening, a thirty day run-in period was used to assess compliance with daily subcutaneous glatiramer acetate injections. Participants who missed more than 3 injections during the run-in period were ineligible to be randomized and were withdrawn from further study participation.
Arm/Group Title Low-dose Vitamin D3 High-dose Vitamin D3
Hide Arm/Group Description Vitamin D3: Patients will be assigned to low dose (600 IU/day) versus high-dose (5000 IU/day) of vitamin D3 as an add-on therapy to glatiramer acetate (Copaxone). Vitamin D3: Patients will be assigned to low dose (600 IU/day) versus high-dose (5000 IU/day) of vitamin D3 as an add-on therapy to glatiramer acetate (Copaxone).
Period Title: Overall Study
Started 83 89
Received Allocated Intervention 83 88
Attended at Least 1 Follow-up Visit 82 83
Completed 68 72
Not Completed 15 17
Arm/Group Title Low-dose Vitamin D3 High-dose Vitamin D3 Total
Hide Arm/Group Description Vitamin D3: Patients will be assigned to low dose (600 IU/day) versus high-dose (5000 IU/day) of vitamin D3 as an add-on therapy to glatiramer acetate (Copaxone). Vitamin D3: Patients will be assigned to low dose (600 IU/day) versus high-dose (5000 IU/day) of vitamin D3 as an add-on therapy to glatiramer acetate (Copaxone). Total of all reporting groups
Overall Number of Baseline Participants 83 89 172
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 83 participants 89 participants 172 participants
34.2  (7.7) 34.5  (7.1) 34.4  (7.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 83 participants 89 participants 172 participants
Female
70
  84.3%
61
  68.5%
131
  76.2%
Male
13
  15.7%
28
  31.5%
41
  23.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 83 participants 89 participants 172 participants
Hispanic or Latino
12
  14.5%
18
  20.2%
30
  17.4%
Not Hispanic or Latino
70
  84.3%
71
  79.8%
141
  82.0%
Unknown or Not Reported
1
   1.2%
0
   0.0%
1
   0.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 83 participants 89 participants 172 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   1.2%
1
   1.1%
2
   1.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
18
  21.7%
11
  12.4%
29
  16.9%
White
61
  73.5%
71
  79.8%
132
  76.7%
More than one race
0
   0.0%
1
   1.1%
1
   0.6%
Unknown or Not Reported
3
   3.6%
5
   5.6%
8
   4.7%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 83 participants 89 participants 172 participants
83
 100.0%
89
 100.0%
172
 100.0%
Expanded Disability Status Scale (EDSS) score   [1] [2] 
Median (Inter-Quartile Range)
Unit of measure:  Units on a scale
Number Analyzed 83 participants 89 participants 172 participants
2.00
(1.00 to 2.50)
2.00
(1.50 to 2.50)
2.00
(1.38 to 2.50)
[1]
Measure Description: The Expanded Disability Status Scale (EDSS) is an ordinal clinical rating scale based on a standard neurological examination and is used to measure global neurologic impairment in people with multiple sclerosis (MS). It ranges from a minimum of 0.0 (normal examination) to 10.0 (death due to MS) in half-point increments.
[2]
Measure Analysis Population Description: Screening EDSS was used for one high-dose vitamin D3 participant with missing EDSS at baseline.
Multiple Sclerosis Functional Composite (MSFC) score   [1] 
Mean (Standard Deviation)
Unit of measure:  Z-score
Number Analyzed 83 participants 89 participants 172 participants
0.5  (0.4) 0.6  (0.5) 0.5  (0.4)
[1]
Measure Description: The Multiple Sclerosis Functional Composite (MSFC) is a three-part measure of disability for people with multiple sclerosis, including measures of leg function/ambulation, arm/hand function and cognitive function. The three independent measures have different units. We take the reciprocal of the arm/hand function test, and then convert all measures to Z-scores. The average of the Z-scores from each measure yields the MSFC composite Z-score. A Z-score of 0 represents the population mean and positive scores indicate less disability.
Low-contrast acuity   [1] 
Mean (Standard Deviation)
Unit of measure:  Letters
Number Analyzed 83 participants 89 participants 172 participants
36  (10) 34  (10) 35  (10)
[1]
Measure Description: Low-contrast acuity was measured as binocular vision on a 2.5% Sloan chart at a distance of 2 meters. The chart is used to test the ability to discriminate gradually smaller gray letters with a 2.5% contrast level against a white background. The low-contrast acuity measure is scored as total letters read and ranges from 0 (no letters read) to 60 (all letters read), with higher scores indicating better low-contrast acuity.
Health-related Quality of Life   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 83 participants 89 participants 172 participants
126  (24) 126  (27) 126  (26)
[1]
Measure Description: The Functional Assessment of Multiple Sclerosis (FAMS) is the quality of life (QOL) instrument used in this trial. It consists of 44 questions and the total score has a possible range of 0 to 176, with higher scores indicating better QOL.
Normalized Brain Parenchymal Volume   [1] 
Mean (Standard Deviation)
Unit of measure:  Microliters
Number Analyzed 74 participants 82 participants 156 participants
1,488,270  (107,046) 1,496,147  (88,025) 1,492,411  (97,270)
[1]
Measure Analysis Population Description: Baseline Brain MRI not available or not of sufficient quality to compute measure for 9 low-dose vitamin D3 and 7 high-dose vitamin D3 participants.
Normalized Gray Matter Volume   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Microliters
Number Analyzed 74 participants 82 participants 156 participants
772,736
(735,433 to 809,191)
781,461
(737,843 to 807,965)
774,469
(736,684 to 808,542)
[1]
Measure Analysis Population Description: Baseline Brain MRI not available or not of sufficient quality to compute measure for 9 low-dose vitamin D3 and 7 high-dose vitamin D3 participants.
1.Primary Outcome
Title Proportion of Subjects That Experience a Relapse
Hide Description Confirmed relapse defined as new or worsening symptoms referable to the central nervous system, lasting at least 24 hours, occurring at least 30 days since the prior attack, accompanied by worsening of the EDSS (>= 0.5 points) or in the Functional Systems (FS) scales (2 points on at least one FS scale or 1 point on >= two FS scales).
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low-dose Vitamin D3 High-dose Vitamin D3
Hide Arm/Group Description:
Vitamin D3: Patients will be assigned to low dose (600 IU/day) versus high-dose (5000 IU/day) of vitamin D3 as an add-on therapy to glatiramer acetate (Copaxone).
Vitamin D3: Patients will be assigned to low dose (600 IU/day) versus high-dose (5000 IU/day) of vitamin D3 as an add-on therapy to glatiramer acetate (Copaxone).
Overall Number of Participants Analyzed 82 83
Measure Type: Number
Unit of Measure: proportion of participants
0.32 0.34
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Low-dose Vitamin D3, High-dose Vitamin D3
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.60
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Low-dose Vitamin D3, High-dose Vitamin D3
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.57
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.17
Confidence Interval (2-Sided) 95%
0.67 to 2.05
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Annualized Relapse Rate
Hide Description Average relapses per year
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low-dose Vitamin D3 High-dose Vitamin D3
Hide Arm/Group Description:
Vitamin D3: Patients will be assigned to low dose (600 IU/day) versus high-dose (5000 IU/day) of vitamin D3 as an add-on therapy to glatiramer acetate (Copaxone).
Vitamin D3: Patients will be assigned to low dose (600 IU/day) versus high-dose (5000 IU/day) of vitamin D3 as an add-on therapy to glatiramer acetate (Copaxone).
Overall Number of Participants Analyzed 82 83
Mean (95% Confidence Interval)
Unit of Measure: relapses per participant per year
0.20
(0.11 to 0.35)
0.34
(0.20 to 0.56)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Low-dose Vitamin D3, High-dose Vitamin D3
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.07
Comments [Not Specified]
Method Andersen Gill model for recurrent events
Comments [Not Specified]
3.Secondary Outcome
Title Number of Relapses Requiring Treatment
Hide Description [Not Specified]
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low-dose Vitamin D3 High-dose Vitamin D3
Hide Arm/Group Description:
Vitamin D3: Patients will be assigned to low dose (600 IU/day) versus high-dose (5000 IU/day) of vitamin D3 as an add-on therapy to glatiramer acetate (Copaxone).
Vitamin D3: Patients will be assigned to low dose (600 IU/day) versus high-dose (5000 IU/day) of vitamin D3 as an add-on therapy to glatiramer acetate (Copaxone).
Overall Number of Participants Analyzed 82 83
Mean (95% Confidence Interval)
Unit of Measure: relapses
0.15
(0.08 to 0.30)
0.28
(0.15 to 0.51)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Low-dose Vitamin D3, High-dose Vitamin D3
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.07
Comments [Not Specified]
Method Negative Binomial Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 1.80
Confidence Interval (2-Sided) 95%
0.94 to 3.45
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Number of New or Enlarging T2 Lesions
Hide Description [Not Specified]
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Participants analyzed had > 1 MRI during the study (baseline and at least one follow-up MRI of sufficient quality).
Arm/Group Title Low-dose Vitamin D3 High-dose Vitamin D3
Hide Arm/Group Description:
Vitamin D3: Patients will be assigned to low dose (600 IU/day) versus high-dose (5000 IU/day) of vitamin D3 as an add-on therapy to glatiramer acetate (Copaxone).
Vitamin D3: Patients will be assigned to low dose (600 IU/day) versus high-dose (5000 IU/day) of vitamin D3 as an add-on therapy to glatiramer acetate (Copaxone).
Overall Number of Participants Analyzed 65 74
Mean (95% Confidence Interval)
Unit of Measure: lesions
1.95
(1.16 to 3.29)
2.88
(1.78 to 4.64)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Low-dose Vitamin D3, High-dose Vitamin D3
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.14
Comments [Not Specified]
Method Negative Binomial Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 1.47
Confidence Interval (2-Sided) 95%
0.88 to 2.46
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Proportion of Participants With Sustained Disability Progression
Hide Description The Expanded Disability Status Scale (EDSS) is an ordinal clinical rating scale based on a standard neurological examination and is used to measure global neurologic impairment in people with multiple sclerosis (MS). It ranges from a minimum of 0.0 (normal examination) to 10.0 (death due to MS) in half-point increments. A participant will be considered to have had sustained progression of disability if there is an increase in the EDSS score at month 12 by at least 1.0 point that is confirmed on the final examination one year later (month 24).
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low-dose Vitamin D3 High-dose Vitamin D3
Hide Arm/Group Description:
Vitamin D3: Patients will be assigned to low dose (600 IU/day) versus high-dose (5000 IU/day) of vitamin D3 as an add-on therapy to glatiramer acetate (Copaxone).
Vitamin D3: Patients will be assigned to low dose (600 IU/day) versus high-dose (5000 IU/day) of vitamin D3 as an add-on therapy to glatiramer acetate (Copaxone).
Overall Number of Participants Analyzed 82 83
Measure Type: Number
Unit of Measure: proportion of participants
0.05 0.08
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Low-dose Vitamin D3, High-dose Vitamin D3
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.60
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
6.Secondary Outcome
Title Change in Multiple Sclerosis Functional Composite (MSFC) Score
Hide Description

The Multiple Sclerosis Functional Composite (MSFC) is a three-part measure of disability for people with multiple sclerosis, including measures of leg function/ambulation, arm/hand function and cognitive function. The three independent measures have different units. We take the reciprocal of the arm/hand function test, and then convert all measures to Z-scores. The average of the Z-scores from each measure yields the MSFC composite Z-score. A Z-score of 0 represents the population mean and positive scores indicate less disability.

The MSFC was measured at baseline and up to 4 more times over 2 years.

Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low-dose Vitamin D3 High-dose Vitamin D3
Hide Arm/Group Description:
Vitamin D3: Patients will be assigned to low dose (600 IU/day) versus high-dose (5000 IU/day) of vitamin D3 as an add-on therapy to glatiramer acetate (Copaxone).
Vitamin D3: Patients will be assigned to low dose (600 IU/day) versus high-dose (5000 IU/day) of vitamin D3 as an add-on therapy to glatiramer acetate (Copaxone).
Overall Number of Participants Analyzed 82 83
Mean (95% Confidence Interval)
Unit of Measure: Z-score
0.051
(0.022 to 0.079)
0.025
(-0.003 to 0.053)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Low-dose Vitamin D3, High-dose Vitamin D3
Comments The average rate of change in MSFC Z-score over time was analyzed using a linear mixed-effects model with unstructured covariance structure and random intercepts. The p-value is a test of whether there is a difference in the rate of change in the MSFC Z-score between treatment arms.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.20
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
7.Secondary Outcome
Title Change in Low-contrast Acuity
Hide Description Low-contrast acuity was measured as binocular vision on a 2.5% Sloan chart at a distance of 2 meters. The chart is used to test the ability to discriminate gradually smaller gray letters with a 2.5% contrast level against a white background. The low-contrast acuity measure is scored as total letters read and ranges from 0 (no letters read) to 60 (all letters read). Low-contrast acuity was measured at baseline and up to 4 more times over 2 years and higher scores indicate better low-contrast acuity.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Participants analyzed did not have an MS relapse between screening and baseline visits and had at least one low-contrast acuity measure at a follow-up visit.
Arm/Group Title Low-dose Vitamin D3 High-dose Vitamin D3
Hide Arm/Group Description:
Vitamin D3: Patients will be assigned to low dose (600 IU/day) versus high-dose (5000 IU/day) of vitamin D3 as an add-on therapy to glatiramer acetate (Copaxone).
Vitamin D3: Patients will be assigned to low dose (600 IU/day) versus high-dose (5000 IU/day) of vitamin D3 as an add-on therapy to glatiramer acetate (Copaxone).
Overall Number of Participants Analyzed 79 78
Mean (95% Confidence Interval)
Unit of Measure: letters
0.82
(-0.08 to 1.71)
1.09
(0.20 to 1.99)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Low-dose Vitamin D3, High-dose Vitamin D3
Comments Rate of change in 2.5% low-contrast acuity was analyzed using a linear mixed effects model with unstructured covariance structure and random intercepts. The p-value is a test of whether there is a difference in the rate of change in low-contrast acuity between treatment arms.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.67
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
8.Secondary Outcome
Title Change in Health-related Quality of Life
Hide Description The Functional Assessment of Multiple Sclerosis (FAMS) questionnaire is the quality of life (QOL) instrument used in this trial. It consists of 44 questions and the total score has a possible range of 0 to 176, with higher scores indicating better QOL. The FAMS questionnaire was obtained at baseline and up to 4 more times over 2 years.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Participants analyzed completed a baseline FAMS questionnaire and at least 1 follow-up FAMS questionnaire.
Arm/Group Title Low-dose Vitamin D3 High-dose Vitamin D3
Hide Arm/Group Description:
Vitamin D3: Patients will be assigned to low dose (600 IU/day) versus high-dose (5000 IU/day) of vitamin D3 as an add-on therapy to glatiramer acetate (Copaxone).
Vitamin D3: Patients will be assigned to low dose (600 IU/day) versus high-dose (5000 IU/day) of vitamin D3 as an add-on therapy to glatiramer acetate (Copaxone).
Overall Number of Participants Analyzed 79 78
Mean (95% Confidence Interval)
Unit of Measure: score on a scale
-0.78
(-2.38 to 0.82)
-2.21
(-3.81 to -0.62)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Low-dose Vitamin D3, High-dose Vitamin D3
Comments Rate of change in quality of life was analyzed using a linear mixed effects model with unstructured covariance structure and random intercepts. The p-value is a test of whether there is a difference in the rate of change in health-related quality of life between treatment arms.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.21
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
9.Secondary Outcome
Title Change in Brain Parenchymal Volume
Hide Description [Not Specified]
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Participants analyzed had > 1 MRI during the study (baseline MRI and at least one follow-up MRI of sufficient quality).
Arm/Group Title Low-dose Vitamin D3 High-dose Vitamin D3
Hide Arm/Group Description:
Vitamin D3: Patients will be assigned to low dose (600 IU/day) versus high-dose (5000 IU/day) of vitamin D3 as an add-on therapy to glatiramer acetate (Copaxone).
Vitamin D3: Patients will be assigned to low dose (600 IU/day) versus high-dose (5000 IU/day) of vitamin D3 as an add-on therapy to glatiramer acetate (Copaxone).
Overall Number of Participants Analyzed 65 74
Mean (95% Confidence Interval)
Unit of Measure: microliters
-0.29
(-0.78 to 0.20)
-0.81
(-1.28 to -0.34)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Low-dose Vitamin D3, High-dose Vitamin D3
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.13
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
10.Secondary Outcome
Title Change in Normalized Gray Matter Volume
Hide Description [Not Specified]
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Participants analyzed had > 1 MRI during the study (baseline MRI and at least one follow-up MRI of sufficient quality).
Arm/Group Title Low-dose Vitamin D3 High-dose Vitamin D3
Hide Arm/Group Description:
Vitamin D3: Patients will be assigned to low dose (600 IU/day) versus high-dose (5000 IU/day) of vitamin D3 as an add-on therapy to glatiramer acetate (Copaxone).
Vitamin D3: Patients will be assigned to low dose (600 IU/day) versus high-dose (5000 IU/day) of vitamin D3 as an add-on therapy to glatiramer acetate (Copaxone).
Overall Number of Participants Analyzed 65 74
Mean (95% Confidence Interval)
Unit of Measure: microliters
-0.15
(-0.73 to 0.45)
-0.87
(-1.43 to -0.31)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Low-dose Vitamin D3, High-dose Vitamin D3
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.08
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
11.Secondary Outcome
Title Change in Cortical Thickness
Hide Description Unable to analyze this outcome measure
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
The quality of the clinical MRI scans acquired for this study prevented the analysis of cortical thickness.
Arm/Group Title Low-dose Vitamin D3 High-dose Vitamin D3
Hide Arm/Group Description:
Vitamin D3: Patients will be assigned to low dose (600 IU/day) versus high-dose (5000 IU/day) of vitamin D3 as an add-on therapy to glatiramer acetate (Copaxone).
Vitamin D3: Patients will be assigned to low dose (600 IU/day) versus high-dose (5000 IU/day) of vitamin D3 as an add-on therapy to glatiramer acetate (Copaxone).
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Development of Hypercalcemia
Hide Description [Not Specified]
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low-dose Vitamin D3 High-dose Vitamin D3
Hide Arm/Group Description:
Vitamin D3: Patients will be assigned to low dose (600 IU/day) versus high-dose (5000 IU/day) of vitamin D3 as an add-on therapy to glatiramer acetate (Copaxone).
Vitamin D3: Patients will be assigned to low dose (600 IU/day) versus high-dose (5000 IU/day) of vitamin D3 as an add-on therapy to glatiramer acetate (Copaxone).
Overall Number of Participants Analyzed 82 83
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
13.Secondary Outcome
Title Development of Nephrolithiasis
Hide Description [Not Specified]
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low-dose Vitamin D3 High-dose Vitamin D3
Hide Arm/Group Description:
Vitamin D3: Patients will be assigned to low dose (600 IU/day) versus high-dose (5000 IU/day) of vitamin D3 as an add-on therapy to glatiramer acetate (Copaxone).
Vitamin D3: Patients will be assigned to low dose (600 IU/day) versus high-dose (5000 IU/day) of vitamin D3 as an add-on therapy to glatiramer acetate (Copaxone).
Overall Number of Participants Analyzed 82 83
Measure Type: Count of Participants
Unit of Measure: Participants
1
   1.2%
2
   2.4%
Time Frame Up to 2 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Low-dose Vitamin D3 High-dose Vitamin D3
Hide Arm/Group Description Vitamin D3: Patients will be assigned to low dose (600 IU/day) versus high-dose (5000 IU/day) of vitamin D3 as an add-on therapy to glatiramer acetate (Copaxone). Vitamin D3: Patients will be assigned to low dose (600 IU/day) versus high-dose (5000 IU/day) of vitamin D3 as an add-on therapy to glatiramer acetate (Copaxone).
All-Cause Mortality
Low-dose Vitamin D3 High-dose Vitamin D3
Affected / at Risk (%) Affected / at Risk (%)
Total   0/82 (0.00%)      0/83 (0.00%)    
Hide Serious Adverse Events
Low-dose Vitamin D3 High-dose Vitamin D3
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/82 (13.41%)      11/83 (13.25%)    
Endocrine disorders     
Hypercalcemia   0/82 (0.00%)  0 0/83 (0.00%)  0
Eye disorders     
Unplanned hospitalization *  0/82 (0.00%)  0 1/83 (1.20%)  1
Gastrointestinal disorders     
Planned hospitalization for elective procedure *  0/82 (0.00%)  0 1/83 (1.20%)  1
Injury, poisoning and procedural complications     
Unplanned hospitalization *  1/82 (1.22%)  1 0/83 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Unplanned hospitalization *  0/82 (0.00%)  0 1/83 (1.20%)  5
Planned hospitalization for elective procedure *  0/82 (0.00%)  0 1/83 (1.20%)  1
Nervous system disorders     
Unplanned hospitalization *  1/82 (1.22%)  1 3/83 (3.61%)  7
Pregnancy, puerperium and perinatal conditions     
Unplanned pregnancy *  5/82 (6.10%)  6 3/83 (3.61%)  3
Psychiatric disorders     
Unplanned hospitalization *  1/82 (1.22%)  2 0/83 (0.00%)  0
Renal and urinary disorders     
Nephrolithiasis *  1/82 (1.22%)  1 2/83 (2.41%)  2
Reproductive system and breast disorders     
Unplanned hospitalization *  0/82 (0.00%)  0 1/83 (1.20%)  1
Planned hospitalization for elective procedure *  1/82 (1.22%)  1 1/83 (1.20%)  1
Respiratory, thoracic and mediastinal disorders     
Unplanned hospitalization *  1/82 (1.22%)  1 1/83 (1.20%)  1
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Low-dose Vitamin D3 High-dose Vitamin D3
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   66/82 (80.49%)      63/83 (75.90%)    
Ear and labyrinth disorders     
Dizziness / increased dizziness *  4/82 (4.88%)  4 5/83 (6.02%)  5
Gastrointestinal disorders     
Abdominal pain / cramp / discomfort *  8/82 (9.76%)  8 4/83 (4.82%)  4
Nausea *  6/82 (7.32%)  7 4/83 (4.82%)  4
Musculoskeletal and connective tissue disorders     
Joint pain or swelling *  7/82 (8.54%)  10 11/83 (13.25%)  12
Myalgia *  10/82 (12.20%)  11 7/83 (8.43%)  7
Nervous system disorders     
Numbness or tingling *  20/82 (24.39%)  22 20/83 (24.10%)  21
Headache / worsened headache / migraine *  13/82 (15.85%)  14 18/83 (21.69%)  22
Fatigue / increased fatigue *  14/82 (17.07%)  14 11/83 (13.25%)  11
Limb pain *  4/82 (4.88%)  6 4/83 (4.82%)  4
Spasm / cramp (non-abdominal) *  3/82 (3.66%)  3 6/83 (7.23%)  6
Psychiatric disorders     
Depression / increased depression / severe depression *  6/82 (7.32%)  6 9/83 (10.84%)  10
Anxiety / worsening anxiety *  3/82 (3.66%)  3 5/83 (6.02%)  6
Sleep disorder *  5/82 (6.10%)  5 11/83 (13.25%)  11
Renal and urinary disorders     
Urinary tract infection *  7/82 (8.54%)  7 2/83 (2.41%)  3
Urinary dysfunction *  3/82 (3.66%)  3 4/83 (4.82%)  6
Respiratory, thoracic and mediastinal disorders     
Upper respiratory infection *  28/82 (34.15%)  44 26/83 (31.33%)  40
Sinusitis *  9/82 (10.98%)  12 4/83 (4.82%)  5
Influenza *  7/82 (8.54%)  7 6/83 (7.23%)  6
Cough *  5/82 (6.10%)  5 5/83 (6.02%)  5
Bronchitis *  5/82 (6.10%)  5 4/83 (4.82%)  4
Sore throat (+/- streptococcal infection) *  4/82 (4.88%)  4 2/83 (2.41%)  2
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Sandra D. Cassard, ScD
Organization: The Johns Hopkins University School of Medicine
Phone: 443-287-4353
EMail: scassar1@jhmi.edu
Layout table for additonal information
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01490502    
Other Study ID Numbers: NA_00049137
First Submitted: December 6, 2011
First Posted: December 13, 2011
Results First Submitted: May 13, 2022
Results First Posted: September 28, 2022
Last Update Posted: September 28, 2022