A Pilot Study to Assess the Relative Safety and Immunology Effects of Low Dose Versus High Dose Cholecalciferol Supplementation in Patients With Multiple Sclerosis
Overview
- Phase
- Phase 1
- Intervention
- Cholecalciferol
- Conditions
- Multiple Sclerosis
- Sponsor
- Johns Hopkins University
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Assess safety of high dose cholecalciferol in patients with multiple sclerosis
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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.
Investigators
Peter A. Calabresi
Professor of Neurology
Johns Hopkins University
Eligibility Criteria
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
Arms & Interventions
High dose cholecalciferol
Patients in the high dose arm will receive 10,000 international units of cholecalciferol daily.
Intervention: Cholecalciferol
Low dose cholecalciferol
Patients enrolled in the low dose arm will receive up to 1000 international units of cholecalciferol daily.
Intervention: Cholecalciferol
Outcomes
Primary Outcomes
Assess safety of high dose cholecalciferol in patients with multiple sclerosis
Time Frame: 3-6 months
Assess the effects of cholecalciferol supplementation on serum immune markers in patients with multiple sclerosis
Time Frame: 3-6 months
Secondary Outcomes
- Assess clinical effects of cholecalciferol supplementation in patients with multiple sclerosis(6 months)