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Trial record 4 of 28 for:    multiple sclerosis | vitamin D

Pharmacokinetics of Vitamin D in Multiple Sclerosis and in Health

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ClinicalTrials.gov Identifier: NCT01667796
Recruitment Status : Completed
First Posted : August 17, 2012
Results First Posted : February 1, 2016
Last Update Posted : March 5, 2019
Sponsor:
Collaborators:
University of California, San Francisco
National Multiple Sclerosis Society
Information provided by (Responsible Party):
Johns Hopkins University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Multiple Sclerosis, Relapsing-remitting
Intervention Dietary Supplement: Vitamin D3
Enrollment 57
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Multiple Sclerosis (MS) Subjects Healthy Controls
Hide Arm/Group Description MS patients Healthy control subjects
Period Title: Overall Study
Started 27 30
Completed 24 29
Not Completed 3 1
Arm/Group Title MS Subjects Healthy Controls Total
Hide Arm/Group Description Female subjects with MS Female subjects without MS Total of all reporting groups
Overall Number of Baseline Participants 27 30 57
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 27 participants 30 participants 57 participants
40.2  (9.2) 37.9  (12.1) 38.9  (10.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 30 participants 57 participants
Female
27
 100.0%
30
 100.0%
57
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 30 participants 57 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
27
 100.0%
30
 100.0%
57
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 27 participants 30 participants 57 participants
27 30 57
1.Primary Outcome
Title Change in Mean Serum Level of 25-hydroxyvitamin D
Hide Description Generalized estimating equations (GEE) with an autoregressive with lag one correlation matrix were used to compare the serially-measured serum 25(OH)D levels between MS patients and Healthy Controls (HCs) to take into account repeated measures and within-subject correlations.
Time Frame Baseline to 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MS Subjects Healthy Controls
Hide Arm/Group Description:
Female subjects with MS
Female subjects without MS
Overall Number of Participants Analyzed 24 29
Mean (Standard Deviation)
Unit of Measure: nmol/L
65.9  (5.9) 82.4  (5.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MS Subjects, Healthy Controls
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method univariate generalized estimating equati
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MS Subjects, Healthy Controls
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments Adjusted for adherence, body mass index, and oral contraceptive use
Method Generalized estimating equation
Comments [Not Specified]
2.Secondary Outcome
Title Change in Percentages of T Cell Subsets (IFNγ+ and IL-17+)
Hide Description Analyzed the mean percentage change in IFNγ+ and IL-17+ cluster of differentiation 4 (CD4) + cells (post- versus pre- supplementation). This represents a change between two time points (90 days versus baseline).
Time Frame Baseline, 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MS Subjects Healthy Controls
Hide Arm/Group Description:
MS patients
Healthy control subjects
Overall Number of Participants Analyzed 11 14
Mean (Standard Deviation)
Unit of Measure: percentage of cells
mean percentage change in IFNγ+ CD4+ cells -5.2  (4.2) -13.2  (3.2)
mean percentage change in IL-17+ CD4+ cells 0.21  (0.77) -0.17  (1.14)
3.Secondary Outcome
Title Gene Expression Microarray
Hide Description We had initially planned to do whole blood gene expression. The experience gained by the laboratory that was to perform this since the original trial was planned was that this measure is too noisy and would not yield meaningful results. Thus, this analysis will no longer be conducted.
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
We had initially planned to do whole blood gene expression. The experience gained by the laboratory that was to perform this since the original trial was planned was that this measure is too noisy and would not yield meaningful results. Thus, this analysis will no longer be conducted.
Arm/Group Title Gene Expression: MS vs HC
Hide Arm/Group Description:
Gene expression analyses have been cancelled as a secondary outcome as laboratory techniques developed since the original study was started indicated that whole blood gene expression is unlikely to be informative.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Change in Cytokine Levels
Hide Description The original plan had been to measure the change in basic serum cytokine levels (e.g. IL-17, interferon gamma; IL-10; pg/microliter). However, due to emerging data suggesting low utility of these measures, this plan was abandoned.
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
Cytokine levels data were not analyzed and are no longer planned to be measured as outcomes.
Arm/Group Title Multiple Sclerosis (MS) Subjects Healthy Controls
Hide Arm/Group Description:
MS patients
Healthy control subjects
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Change in Percentage of B Cells
Hide Description The change in percentage (day 90-baseline) was originally planned for study. Due to the limited number of patients with samples this plan was abandoned.
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
B Cell data were not analyzed and are no longer planned to be measured as outcomes.
Arm/Group Title Multiple Sclerosis (MS) Subjects Healthy Controls
Hide Arm/Group Description:
MS patients
Healthy control subjects
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title MS Subjects Healthy Controls
Hide Arm/Group Description MS patients Healthy control subjects
All-Cause Mortality
MS Subjects Healthy Controls
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
MS Subjects Healthy Controls
Affected / at Risk (%) Affected / at Risk (%)
Total   0/27 (0.00%)   0/30 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
MS Subjects Healthy Controls
Affected / at Risk (%) Affected / at Risk (%)
Total   0/27 (0.00%)   1/30 (3.33%) 
Cardiac disorders     
Palpitations [1]  0/27 (0.00%)  1/30 (3.33%) 
[1]
A control got palpitations. Cardiac workup: rare premature atrial and ventricular contractions; the person then reported remote atrial fibrillation (not disclosed at screening visit). This was not deemed to be related to vitamin D supplementation.
The generalizability of the findings of this study (beyond female Caucasians) has to be further tested. It is possible that there were unmeasured confounders influencing results.
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
Layout table for Results Point of Contact information
Name/Title: Ellen Mowry
Organization: Johns Hopkins
Phone: 4106141522
EMail: vitamindtrialms@jhmi.edu
Layout table for additonal information
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01667796     History of Changes
Other Study ID Numbers: NA_00049428
FG-1507-05231 ( Other Grant/Funding Number: National Multiple Sclerosis Society )
First Submitted: August 13, 2012
First Posted: August 17, 2012
Results First Submitted: August 25, 2015
Results First Posted: February 1, 2016
Last Update Posted: March 5, 2019