Vitamin D Supplementation in Multiple Sclerosis
Low vitamin D levels have been shown to increase a person's risk of developing multiple sclerosis (MS), and patients with MS who have lower vitamin D levels are at increased risk of having attacks. However, it is not known if giving supplemental vitamin D to those with MS reduces the risk of attacks, and some research suggests that vitamin D could even be harmful to people with MS. In this clinical trial, patients with relapsing-remitting MS will receive high-dose or low-dose oral vitamin D in addition to an approved therapy for MS, glatiramer acetate. Patients will be evaluated for two years, and the effect of high-dose vitamin D supplementation on the rate of MS attacks and on the number of new lesions and change in brain volume on MRI will be determined. Establishing this association will have major implications for the treatment of individuals with MS throughout the world.
Study Start Date
Estimated Completion Date
- Drug: Vitamin D3
- Internal Medicine: Clinical Pharmacology,Neurology
- Neurology: Demyelinating Disorders
- Pharmacy: Drug Trials
- Multiple Sclerosis
- Multiple Sclerosis, Relapsing-Remitting
Johns Hopkins University -- NMSS 4407A2/1
Johns Hopkins University
1. Must meet MAGNIMS criteria for relapsing-remitting MS
2. Age 18 to 50 years
3. EDSS score ? 4.0
4. MS disease duration ? 10 years if McDonald RRMS ? 1 year if meets MAGNIMS RRMS
criteria but not McDonald RRMS criteria
5. If the patient meets the McDonald RRMS criteria (rather than McDonald CIS that is now
classified as MAGNIMS MS):
- Must have had one clinical attack in past two years AND at least one new silent T2 or gadolinium-enhancing lesion on brain MRI within the past year OR
- Must have had two clinical attacks in past two years, one of which occurred in the past year 6. Females of child-bearing age must be willing to use at least one form of pregnancy prevention throughout the study. 7. Must have had a 25-hydroxyvitamin D level of ? 15 ng/mL within past 30 days 8. Must be willing to stop taking additional supplemental vitamin D, except as part of a multivitamin, and must be willing to not take cod liver oil.
1. Not be pregnant or nursing
2. No ongoing renal or liver disease
3. No known history of nephrolithiasis, hypercalcemia, sarcoidosis or other serious
chronic illness including cancer (other than basal cell or squamous cell carcinoma of
the skin), cardiac disease, or HIV.
4. No ongoing hyperthyroidism or active infection with Mycobacterium species
5. No known gastrointestinal disease (ulcerative colitis, Crohn's disease, celiac
disease/gluten intolerance) or use of medications associated with malabsorption.
6. No history of self-reported alcohol or substance abuse in past six months.
7. No prior history of treatment with rituximab, any chemotherapeutic agent, or total
lymphoid irradiation. No treatment in the past six months with natalizumab,
fingolimod, or fumarate. If patient has received glatiramer acetate, they have not
been exposed to more than three months of treatment. No treatment with other
unapproved therapies for MS.
8. No use of interferon beta or glatiramer acetate therapy for one month prior to
9. No use of more than 1,000 IU vitamin D3 daily in the three months prior to screening
10. No condition that would limit the likelihood of completing the MRI procedures
11. No use of thiazide diuretics, digoxin, diltiazem, verapamil, cimetidine, heparin,
low-molecular weight heparin, phenytoin, phenobarbital, carbamazepine, routine
corticosteroids (eg scheduled monthly steroids, daily, etc), rifampin, or
12. No steroids within a month of screening.
13. Not suicidal at screening visit (ineligible if answers "yes" to question 1 of
screening Columbia Suicide Severity Rating Scale (C-SSRS) in PAST 2 MONTHS or
answers "yes" to questions 2-5 on C-SSRS for PAST 6 MONTHS or answers "yes" to
suicidal attempts or preparatory attempts in PAST 5 YEARS ,
14. Serum calcium >0.2 mg/dL above upper limit of normal.
18 Years to 50 Years
Accepts Healthy Volunteers
Study Locations and Contact Information (1)
|Columbia University - New York, New York||44.8 miles||None||None||None|