NCT00644904

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: University of Toronto · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

• Multiple Sclerosis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Vitamin D3
DIETARY_SUPPLEMENT	Vitamin D3

Timeline

• Start date: 2006-07-01
• Primary completion: 2008-02-01
• Completion: 2008-02-01
• First posted: 2008-03-27
• Last updated: 2008-03-28

Locations

1 site across 1 country: Canada