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

Phase 1

Completed

• Conditions: Multiple Sclerosis; Vitamin D Deficiency
• Interventions: Drug: Cholecalciferol

• Registration Number: NCT01024777
• Lead Sponsor: Johns Hopkins University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-12-02
• Study First Submitted QC: 2009-12-02
• Study First Posted: 2009-12-03
• Study Start: 2010-03
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-05
• Last Update Posted: 2013-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High dose cholecalciferol	Cholecalciferol	Patients in the high dose arm will receive 10,000 international units of cholecalciferol daily.
Low dose cholecalciferol	Cholecalciferol	Patients enrolled in the low dose arm will receive up to 1000 international units of cholecalciferol daily.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Assess clinical effects of cholecalciferol supplementation in patients with multiple sclerosis	6 months

Trial Locations

Locations (1)

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States