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

Johns Hopkins University

Status and phase: Completed; Phase 1

Conditions: Vitamin D Deficiency; Multiple Sclerosis

Treatments: Drug: Cholecalciferol

Study type: Interventional

Funder types: Other

Identifiers

NCT01024777

NA_00023005

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

High dose cholecalciferol

Active Comparator group

Description:

Patients in the high dose arm will receive 10,000 international units of cholecalciferol daily.

Treatment:

Drug: Cholecalciferol

Drug: Cholecalciferol

Low dose cholecalciferol

Active Comparator group

Description:

Patients enrolled in the low dose arm will receive up to 1000 international units of cholecalciferol daily.

Treatment:

Drug: Cholecalciferol

Drug: Cholecalciferol