Vitamin D Supplementation in Multiple Sclerosis
A Randomized Controlled Trial of Vitamin D Supplementation in Multiple Sclerosis
What it found
The main measure did not show a significant benefit.
| Measure | Estimate | 95% CI | p |
|---|---|---|---|
| Proportion of Subjects That Experience a Relapse | Hazard Ratio (HR) 1.17 | 0.67–2.05 | 0.57 |
| Proportion of Subjects That Experience a Relapse | 0.60 |
Statistical analysis as posted on ClinicalTrials.gov.
What was tested
Treatment tested
- Cholecalciferol
Vitamin D receptor agonist
Results by group
Proportion of Subjects That Experience a Relapse
2 years
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Low-dose Vitamin D3 | 0.32 proportion of participants | 82 | |
| High-dose Vitamin D3 | 0.34 proportion of participants | 83 |
Low-dose Vitamin D3
High-dose Vitamin D3
p = 0.60
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Low-dose Vitamin D3 | 82 | 11 (13.4%) | 0 |
| High-dose Vitamin D3 | 83 | 11 (13.3%) | 0 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Proportion of Subjects That Experience a Relapse
2 years
Disability progressionRelapses
Other measures (12)
Annualized Relapse Rate
2 years
RelapsesNumber of Relapses Requiring Treatment
2 years
RelapsesNumber of New or Enlarging T2 Lesions
2 years
MRI lesionsProportion of Participants With Sustained Disability Progression
2 years
Disability progressionChange in Multiple Sclerosis Functional Composite (MSFC) Score
2 years
Disability progressionThinking and memoryArm and hand functionChange in Low-contrast Acuity
2 years
VisionChange in Health-related Quality of Life
2 years
Quality of life (reported by participants)Change in Brain Parenchymal Volume
2 years
Change in Normalized Gray Matter Volume
2 years
Brain volume lossChange in Cortical Thickness
2 years
Who could take part
Relapsing MS · 18 to 50
Show the full criteria
Inclusion criteria
* Must meet Magnetic Resonance Imaging in MS (MAGNIMS) criteria for relapsing-remitting MS * Age 18 to 50 years * Expanded Disability Status Scale (EDSS) score ≤ 4.0 * MS disease duration ≤ 10 years if McDonald Relapse Remitting Multiple Sclerosis (RRMS;) ≤ 1 year if meets MAGNIMS RRMS criteria but not McDonald RRMS criteria * If the patient meets the McDonald RRMS criteria (rather than McDonald Clinically Isolated Syndrome (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 * Females of child-bearing age must be willing to use at least one form of pregnancy prevention throughout the study. * Must have had a 25-hydroxyvitamin D level of ≥ 15 ng/mL within past 30 days * 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.
Exclusion criteria
* Not be pregnant or nursing * No ongoing renal or liver disease * 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. * No ongoing hyperthyroidism or active infection with Mycobacterium species * No known gastrointestinal disease (ulcerative colitis, Crohn's disease, celiac disease/gluten intolerance) or use of medications associated with malabsorption. * No history of self-reported alcohol or substance abuse in past six months. * 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. * No use of interferon beta or glatiramer acetate therapy for one month prior to screening * No use of more than 1,000 IU vitamin D3 daily in the three months prior to screening * No condition that would limit the likelihood of completing the MRI procedures * 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 cholestyramine. * No steroids within a month of screening. * 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 , http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM225130.pdf). * Serum calcium >0.2 mg/dL above upper limit of normal.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Results
Vitamin D Supplementation Modulates T Cell-Mediated Immunity in Humans: Results from a Randomized Control Trial.J Clin Endocrinol Metab · 2016
Results
The vitamin D to ameliorate multiple sclerosis (VIDAMS) trial: study design for a multicenter, randomized, double-blind controlled trial of vitamin D in multiple sclerosis.Contemp Clin Trials · 2014
Results
Cassard SD, Fitzgerald KC, Qian P, Emrich SA, Azevedo CJ, Goodman AD, Sugar EA, Pelletier D, Waubant E, Mowry EM. High-dose vitamin D3 supplementation in relapsing-remitting multiple sclerosis: a randomised clinical trial. EClinicalMedicine. 2023 Apr 13;59:101957. doi: 10.1016/j.eclinm.2023.101957. eCollection 2023 May.
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History
Started
Mar 2012
Main results due
May 2021
Finished
May 2021
Results posted
Sept 2022