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NCT01024777 Clinical Trial

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

Multiple Sclerosis Clinical Trial

Official title:
A Pilot Study to Assess the Relative Safety and Immunology Effects of Low Dose Versus High Dose Cholecalciferol Supplementation in Patients With Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01024777
Other study ID # NA_00023005
Secondary ID
Status Completed
Phase Phase 1
First received December 2, 2009
Last updated February 5, 2013
Start date March 2010
Est. completion date January 2013

Study information
Verified date February 2013
Source Johns Hopkins University
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationUnited States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date January 2013
Est. primary completion date January 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 55 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Cholecalciferol
Cholecalciferol (Vitamin D3) 10,000 IU in tablet form will be taken once daily for the duration of the trial (6 months)
• Cholecalciferol
Cholecalciferol (Vitamin D3) 400 IU in tablet form will be taken once daily for the duration of the trial (6 months)

Locations
Country Name City State
United States Johns Hopkins University Baltimore Maryland

Sponsors (1)
Lead Sponsor Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Assess safety of high dose cholecalciferol in patients with multiple sclerosis 3-6 months Yes
Primary Assess the effects of cholecalciferol supplementation on serum immune markers in patients with multiple sclerosis 3-6 months No
Secondary Assess clinical effects of cholecalciferol supplementation in patients with multiple sclerosis 6 months No
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