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

Completed · Phase 1

Conditions studied: Multiple Sclerosis, Vitamin D Deficiency

In brief

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.

Key facts

Study ID

NCT01024777

Run by

Johns Hopkins University

People needed

40

Starts

2010-03-01

Expected to finish

2013-01-01

Last updated by the study team

2013-02-06

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Johns Hopkins University — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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