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

February 5, 2013 updated by: Peter A. Calabresi, Johns Hopkins University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: High dose cholecalciferol
Patients in the high dose arm will receive 10,000 international units of cholecalciferol daily.
Drug: Cholecalciferol
Cholecalciferol (Vitamin D3) 10,000 IU in tablet form will be taken once daily for the duration of the trial (6 months)
Other Names:
  • Vitamin D3
Drug: Cholecalciferol
Cholecalciferol (Vitamin D3) 400 IU in tablet form will be taken once daily for the duration of the trial (6 months)
Other Names:
  • Vitamin D3
Active Comparator: Low dose cholecalciferol
Patients enrolled in the low dose arm will receive up to 1000 international units of cholecalciferol daily.
Drug: Cholecalciferol
Cholecalciferol (Vitamin D3) 10,000 IU in tablet form will be taken once daily for the duration of the trial (6 months)
Other Names:
  • Vitamin D3
Drug: Cholecalciferol
Cholecalciferol (Vitamin D3) 400 IU in tablet form will be taken once daily for the duration of the trial (6 months)
Other Names:
  • Vitamin D3

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assess safety of high dose cholecalciferol in patients with multiple sclerosis
Time Frame: 3-6 months
3-6 months
Assess the effects of cholecalciferol supplementation on serum immune markers in patients with multiple sclerosis
Time Frame: 3-6 months
3-6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Assess clinical effects of cholecalciferol supplementation in patients with multiple sclerosis
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Investigators

  • Principal Investigator: Peter Calabresi, MD, Johns Hopkins University
  • Principal Investigator: John Ratchford, MD, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

December 2, 2009

First Submitted That Met QC Criteria

December 2, 2009

First Posted (Estimate)

December 3, 2009

Study Record Updates

Last Update Posted (Estimate)

February 6, 2013

Last Update Submitted That Met QC Criteria

February 5, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NA_00023005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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