Safety and Immunologic Effect of Low Dose Versus High Dose Vitamin D3 in Multiple Sclerosis

• Status: Completed
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Treatments: Cholecalciferol; Ergocalciferols; Vitamin D; Vitamins

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