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

NCT00644904 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2008-03-28

No results posted yet for this study

Summary

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Vitamin D3

DIETARY_SUPPLEMENT

Vitamin D3

Sponsors & Collaborators

  • Direct MS-Proactive Charity

    collaborator UNKNOWN

  • Multiple Sclerosis Society of Canada

    collaborator OTHER

  • University of Toronto

    lead OTHER

Principal Investigators

  • Jodie M Burton, MD · St. Michael's Hospital, University of Toronto

  • Paul W O'Connor, MD, MSc · St. Michael's Hospital, University of Toronto

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-07-31
Primary Completion
2008-02-29
Completion
2008-02-29

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00644904 on ClinicalTrials.gov