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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
Sponsor:
Collaborator:
University of California, San Francisco
Information provided by (Responsible Party):
Johns Hopkins University

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.

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)
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

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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).

  2. 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.

  3. 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.

  4. 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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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)


Information from the National Library of Medicine

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


Locations
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
Sponsors and Collaborators
Johns Hopkins University
University of California, San Francisco
Investigators
Principal Investigator: Ellen M Mowry, MD, MCR Johns Hopkins University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01667796     History of Changes
Other Study ID Numbers: NA_00049428
First Posted: August 17, 2012    Key Record Dates
Results First Posted: February 1, 2016
Last Update Posted: November 5, 2018
Last Verified: April 2018

Keywords provided by Johns Hopkins University:
Multiple sclerosis
Healthy controls
Pharmacokinetics
Vitamin D

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents