Status:
COMPLETED
Safety Trial of High Dose Oral Vitamin D3 With Calcium in Multiple Sclerosis
Lead Sponsor:
University of Toronto
Collaborating Sponsors:
Direct MS-Proactive Charity
Multiple Sclerosis Society of Canada
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
PHASE2
Brief 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 exam...
Eligibility Criteria
Inclusion
- Clinically definite MS
- Age 18-55
- EDSS 0-6.5
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00644904
Start Date
July 1 2006
End Date
February 1 2008
Last Update
March 28 2008
Active Locations (1)
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1
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8