Pharmacokinetics of Vitamin D in Multiple Sclerosis and in Health

Not Applicable

Completed

Brief Summary: This is a pilot study of oral vitamin D supplementation to determine if patients with Multiple Sclerosis (MS) and healthy individuals attain a similar increase in serum 25-hydroxyvitamin D levels. The investigators will also assess whether the immunologic or relevant gene expression response to oral vitamin D supplementation differs in patients with MS and healthy controls.

Recruitment & Eligibility

Inclusion Criteria

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)

Arm && Interventions

Group	Intervention	Description
Vitamin D3	Vitamin D3	Both those with MS and healthy controls will be given vitamin D3 5000 IU/day by mouth for 90 days.

Primary Outcome Measures

Name	Time	Method
Change in Mean Serum Level of 25-hydroxyvitamin D	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.

Secondary Outcome Measures

Name	Time	Method
Gene Expression Microarray	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	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 Percentages of T Cell Subsets (IFNγ+ and IL-17+)	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).
Change in Percentage of B Cells	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.

Locations (2): Johns Hopkins University
🇺🇸
Baltimore, Maryland, United States
University of California, San Francisco
🇺🇸
San Francisco, California, United States