Pharmacokinetics of Vitamin D in Multiple Sclerosis and in Health

This study is currently recruiting participants.
Verified March 2014 by Johns Hopkins University
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: March 17, 2014
Last verified: March 2014
  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: 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cytokine levels and percentages of T and B cells [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Gene expression microarray [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: November 2010
Estimated Study Completion Date: March 2014
Estimated 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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01667796

Contacts
Contact: Ellen Mowry, MD, MCR vitamindtrialms@jhmi.edu

Locations
United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Principal Investigator: Emmanuelle Waubant, MD, PhD         
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21287
Principal Investigator: Ellen M Mowry, MD, MCR         
Sponsors and Collaborators
Johns Hopkins University
University of California, San Francisco
Investigators
Principal Investigator: Ellen M Mowry, MD, MCR Johns Hopkins University
  More Information

No publications provided

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
Last Updated: March 17, 2014
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:
Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on April 17, 2014