Safety Trial of High Dose Oral Vitamin D3 With Calcium in Multiple Sclerosis (VitD4MS)

March 27, 2008 updated by: University of Toronto

A Phase I/II Dose-Escalation Trial of Vitamin D3 With Calcium Supplementation in Patients With Multiple Sclerosis

Vitamin D likely plays a role in the geography of Multiple Sclerosis (MS), and patients at risk and with MS have relatively low Vitamin D levels compared to their normal counterparts.

This trial examines the safety of high dose oral Vitamin D3 titrated up to a maximum of 40,000 IU per day over a 12 month period. Fifty patients matched for MS and non-MS characteristics will be divided into two groups: one group receiving the high dose Vitamin D regimen, and the other restricted to a maximum of 4000 IU per day. The hypothesis is that patients with MS can tolerate seemingly high doses of Vitamin D3 without adverse events and/or calcium-related abnormalities. It is also hypothesized that those receiving the higher doses will demonstrate improved relapse and disability status compared to controls, and that the treatment group will show improved markers of bone health and immune indicators of reduced inflammation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Phase 2
  • 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

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5B 1W8
        • St. Michael's Hospital

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:

  • Clinically definite MS
  • Age 18-55
  • EDSS 0-6.5

Exclusion Criteria:

  • EDSS => 7.0
  • Current Vitamin D3 use >4000 IU/d
  • Baseline (25(OH)D) level <20 mmol/L (frank deficiency) and >150 mmol/L
  • Pregnancy or inability/unwillingness to use contraception
  • History of cardiac arrhythmia
  • History of renal disease and nephrolithiasis
  • History of granulomatous disease or lymphoma
  • Relapse activity or steroid use in the past 60 days

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
Starting dose of 4,000 IU per day of Vitamin D3 titrating up to a dose of 40,000 IU per day of Vitamin D3 by month six. In the second six-month part of the trial, patients titrate back down to 4,000 IU per day of Vitamin D3 and then discontinue it completely at the end of the 12 month trial period.
Dietary supplement: Vitamin D3
Other: Control
Patients are allowed to supplement with up to 4,000 IU per day of Vitamin D3 if desired.
Dietary supplement: Vitamin D3

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serum calcium
Time Frame: at each dose change
at each dose change

Secondary Outcome Measures

Outcome Measure
Time Frame
Serum 25(OH)D
Time Frame: at each dose change
at each dose change
EDSS
Time Frame: at screening vs. end of trial
at screening vs. end of trial
N-telopeptide (bone marker)
ALP/AST/ALT
Time Frame: at each dose change
at each dose change
Creatinine/urea
Time Frame: at each dose change
at each dose change
EKG
Time Frame: at screening and end of trial
at screening and end of trial
Renal ultrasound
Time Frame: at screening, mid-trial and end of trial
at screening, mid-trial and end of trial
Cytokine profile/MMP/lymphocyte response assay
Annualized relapse rate
Time Frame: year prior to trial versus year of trial
year prior to trial versus year of trial
PTH
Time Frame: at each dose change
at each dose change

Collaborators and Investigators

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

Sponsor

University of Toronto

Collaborators

Multiple Sclerosis Society of Canada
Direct MS-Proactive Charity

Investigators

  • Principal Investigator: Jodie M Burton, MD, St. Michael's Hospital, University of Toronto
  • Principal Investigator: Paul W O'Connor, MD, MSc, St. Michael's Hospital, University of Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

July 1, 2006

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

March 24, 2008

First Submitted That Met QC Criteria

March 26, 2008

First Posted (Estimate)

March 27, 2008

Study Record Updates

Last Update Posted (Estimate)

March 28, 2008

Last Update Submitted That Met QC Criteria

March 27, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REB05-147

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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