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 : March 5, 2019
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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 |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Other |
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 |

Arm | Intervention/treatment |
---|---|
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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Female
- Healthy or multiple sclerosis
- Aged 18 to 60
- Body mass index is between 18 kg/m2 and 30 kg/m2
- Screening 25-hydroxyvitamin D level ≤ 75 nmol/L (30 ng/mL)
- White race
- Non-Hispanic ethnicity
- Willing to use birth control during study
- Willing to not use tanning bed during study
If subject has multiple sclerosis:
- Relapsing-remitting MS, as defined by McDonald 2005 criteria
- Screening Expanded Disability Status Scale score ≤ 3.0
- Using no medication for MS, or taking Copaxone, (glatiramer acetate), interferons, or natalizumab
Exclusion Criteria:
- Pregnant or nursing
- Taking multivitamin & unwilling to remain off it during study
- Taking cod liver oil & unwilling to remain off it during study
- On a fat-restricted diet
- History of renal disease or nephrolithiasis (kidney stones)
- History of liver disease
- Taking thiazide diuretics
- History of hyperthyroidism
- History of infection with Mycobacterium species
- History of sarcoidosis
- History of cancer
- History of cardiac disease
- History of HIV
- History of gastrointestinal disorder
- Taking medications that interfere with gastrointestinal absorption
- Cigarette smoker in past month
- Use of illicit drugs in past month
- Use of steroids in past month
- History of hypercalcemia, and screening serum calcium ≤ 10 mg/dL (UCSF) or ≤ 10.7 mg/dL (Johns Hopkins)
- History of hypercalciuria
- Evidence of anemia (Hgb <11.0 g/dL)
- History of other serious medical conditions
- Taking medications that involve the P450 system or may interact with vitamin D (digoxin, diltiazem, verapamil, cimetidine, heparin, or low-molecular weight heparin)
- Other concerns about safety from the perspective of the treating physician
If subject has MS:
-History of major heat sensitivity (leading to sun-avoidant behaviors)

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 |
Responsible Party: | Johns Hopkins University |
ClinicalTrials.gov Identifier: | NCT01667796 |
Other Study ID Numbers: |
NA_00049428 FG-1507-05231 ( Other Grant/Funding Number: National Multiple Sclerosis Society ) |
First Posted: | August 17, 2012 Key Record Dates |
Results First Posted: | February 1, 2016 |
Last Update Posted: | March 5, 2019 |
Last Verified: | March 2019 |
Multiple sclerosis Healthy controls Pharmacokinetics Vitamin D |
Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Sclerosis Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases |
Vitamin D Cholecalciferol Vitamins Micronutrients Nutrients Growth Substances Physiological Effects of Drugs Bone Density Conservation Agents Calcium-Regulating Hormones and Agents |