Multiple Sclerosis, Vitamin D Deficiency
Conditions
Keywords
cholecalciferol, multiple sclerosis, vitamin D, D3
Brief summary
The purpose of this study is to determine the safety and the immunologic effects of supplementation with low-dose and high-dose cholecalciferol (vitamin D3) in patients with multiple sclerosis.
Interventions
DRUGCholecalciferol
Cholecalciferol (Vitamin D3) 10,000 IU in tablet form will be taken once daily for the duration of the trial (6 months)
Sponsors
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Between ages of 18-55 years (inclusive) * Serum 25(OH) vitamin D levels between 20-50 ng/mL and a candidate for vitamin D supplementation * Patients with or without immunomodulatory therapy for RRMS * Diagnosis of multiple sclerosis
Exclusion criteria
* Serum 25(OH) vitamin D deficient level \< 20 ng/mL * High dose vitamin D supplementation in the past 3 months * Pregnancy * History of tuberculosis, hyperparathyroidism, sarcoidosis or kidney stones * Baseline serum creatinine above 1.5 * Hypersensitivity to vitamin D preparations * Milk allergy * Unable to consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assess safety of high dose cholecalciferol in patients with multiple sclerosis | 3-6 months |
| Assess the effects of cholecalciferol supplementation on serum immune markers in patients with multiple sclerosis | 3-6 months |
Secondary
| Measure | Time frame |
|---|---|
| Assess clinical effects of cholecalciferol supplementation in patients with multiple sclerosis | 6 months |
Countries
United States
Outcome results
None listed