Pharmacokinetics of Vitamin D in Multiple Sclerosis and in Health
|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: NCT01667796|
Recruitment Status : Completed
First Posted : August 17, 2012
Results First Posted : February 1, 2016
Last Update Posted : April 4, 2017
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis, Relapsing-remitting||Dietary Supplement: Vitamin D3||Phase 1|
|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 HCs to take into account repeated measures and within-subject correlations.
- Cytokine Levels and Percentages of T and B Cells [ Time Frame: 90 days ]These data have not yet been fully analyzed.
- Gene Expression Microarray [ Time Frame: 90 days ]These data have not yet been generated
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|