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 : November 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis, Relapsing-remitting||Dietary Supplement: Vitamin D3||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||57 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pharmacodynamic and Immunologic Effects of Vitamin D Supplementation in Patients With Multiple Sclerosis and Healthy Controls|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||March 2014|
Experimental: Vitamin D3
Both those with MS and healthy controls will be given vitamin D3 5000 IU/day by mouth for 90 days.
Dietary Supplement: Vitamin D3
- Change in Mean Serum Level of 25-hydroxyvitamin D [ Time Frame: Baseline to 90 days ]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.
- Change in Percentages of T Cell Subsets (IFNγ+ and IL-17+) [ Time Frame: Baseline, 90 days ]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).
- Gene Expression Microarray [ Time Frame: 90 days ]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.
- Change in Cytokine Levels [ Time Frame: 90 days ]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.
- Change in Percentage of B Cells [ Time Frame: 90 days ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01667796
|United States, California|
|University of California, San Francisco|
|San Francisco, California, United States, 94143|
|United States, Maryland|
|Johns Hopkins University|
|Baltimore, Maryland, United States, 21287|
|Principal Investigator:||Ellen M Mowry, MD, MCR||Johns Hopkins University|