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Clinical Trials/NCT01667796
NCT01667796CompletedNot Applicable

Pharmacodynamic and Immunologic Effects of Vitamin D Supplementation in Patients With Multiple Sclerosis and Healthy Controls

Johns Hopkins University4 sites in 1 country57 target enrollmentStarted: November 2010Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
57
Locations
4
Primary Endpoint
Change in Mean Serum Level of 25-hydroxyvitamin D
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •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)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Gene Expression Microarray(90 days)
  • Change in Cytokine Levels(90 days)
  • Change in Percentages of T Cell Subsets (IFNγ+ and IL-17+)(Baseline, 90 days)
  • Change in Percentage of B Cells(90 days)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (4)

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