Pharmacokinetics of Vitamin D in Multiple Sclerosis and in Health

This study has been completed.
Sponsor:
Collaborator:
University of California, San Francisco
Information provided by (Responsible Party):
Ellen M. Mowry, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01667796
First received: August 13, 2012
Last updated: December 29, 2015
Last verified: December 2015
  Purpose
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 Intervention Phase
Multiple Sclerosis, Relapsing-remitting
Dietary Supplement: Vitamin D3
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Pharmacodynamic and Immunologic Effects of Vitamin D Supplementation in Patients With Multiple Sclerosis and Healthy Controls

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Change in Mean Serum Level of 25-hydroxyvitamin D [ Time Frame: Baseline to 90 days ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Cytokine Levels and Percentages of T and B Cells [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    These data have not yet been fully analyzed.

  • Gene Expression Microarray [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    These data have not yet been generated


Enrollment: 57
Study Start Date: November 2010
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Genders 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)

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Responsible Party: Ellen M. Mowry, Assistant Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01667796     History of Changes
Other Study ID Numbers: JH067055 
Study First Received: August 13, 2012
Results First Received: August 25, 2015
Last Updated: December 29, 2015
Health Authority: United States: Data and Safety Monitoring Board

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

ClinicalTrials.gov processed this record on August 24, 2016