Safety Trial of High Dose Oral Vitamin D3 With Calcium in Multiple Sclerosis (VitD4MS)
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|ClinicalTrials.gov Identifier: NCT00644904|
Recruitment Status : Completed
First Posted : March 27, 2008
Last Update Posted : March 28, 2008
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.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Dietary Supplement: Vitamin D3||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||49 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Dose-Escalation Trial of Vitamin D3 With Calcium Supplementation in Patients With Multiple Sclerosis|
|Study Start Date :||July 2006|
|Actual Primary Completion Date :||February 2008|
|Actual Study Completion Date :||February 2008|
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
Patients are allowed to supplement with up to 4,000 IU per day of Vitamin D3 if desired.
Dietary Supplement: Vitamin D3
- Serum calcium [ Time Frame: at each dose change ]
- Serum 25(OH)D [ Time Frame: at each dose change ]
- EDSS [ Time Frame: at screening vs. end of trial ]
- N-telopeptide (bone marker)
- ALP/AST/ALT [ Time Frame: at each dose change ]
- Creatinine/urea [ Time Frame: at each dose change ]
- EKG [ Time Frame: at screening and end of trial ]
- Renal ultrasound [ Time Frame: 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 ]
- PTH [ Time Frame: at each dose change ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00644904
|St. Michael's Hospital|
|Toronto, Ontario, Canada, M5B 1W8|
|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|