Pharmacokinetics of Vitamin D in Multiple Sclerosis and in Health
This study is currently recruiting participants.
Verified February 2013 by Johns Hopkins University
Sponsor:
Johns Hopkins University
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: February 18, 2013
Last verified: February 2013
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Purpose
This is a pilot study of oral vitamin D supplementation to determine if patients with 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: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (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: | February 18, 2013 |
| 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 June 18, 2013