- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00644904
Safety Trial of High Dose Oral Vitamin D3 With Calcium in Multiple Sclerosis (VitD4MS)
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5B 1W8
- St. Michael's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
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Other: Control
Patients are allowed to supplement with up to 4,000 IU per day of Vitamin D3 if desired.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Serum calcium
Time Frame: at each dose change
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at each dose change
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Serum 25(OH)D
Time Frame: at each dose change
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at each dose change
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EDSS
Time Frame: at screening vs. end of trial
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at screening vs. end of trial
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N-telopeptide (bone marker)
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ALP/AST/ALT
Time Frame: at each dose change
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at each dose change
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Creatinine/urea
Time Frame: at each dose change
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at each dose change
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EKG
Time Frame: at screening and end of trial
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at screening and end of trial
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Renal ultrasound
Time Frame: at screening, mid-trial and end of trial
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at screening, mid-trial and end of trial
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Cytokine profile/MMP/lymphocyte response assay
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Annualized relapse rate
Time Frame: year prior to trial versus year of trial
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year prior to trial versus year of trial
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PTH
Time Frame: at each dose change
|
at each dose change
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Collaborators and Investigators
Sponsor
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
General Publications
- Kimball SM, Ursell MR, O'Connor P, Vieth R. Safety of vitamin D3 in adults with multiple sclerosis. Am J Clin Nutr. 2007 Sep;86(3):645-51. doi: 10.1093/ajcn/86.3.645.
- Kimball S, Vieth R, Dosch HM, Bar-Or A, Cheung R, Gagne D, O'Connor P, D'Souza C, Ursell M, Burton JM. Cholecalciferol plus calcium suppresses abnormal PBMC reactivity in patients with multiple sclerosis. J Clin Endocrinol Metab. 2011 Sep;96(9):2826-34. doi: 10.1210/jc.2011-0325. Epub 2011 Jun 22.
- Kimball SM, Burton JM, O'Connor PG, Vieth R. Urinary calcium response to high dose vitamin D3 with calcium supplementation in patients with multiple sclerosis. Clin Biochem. 2011 Jul;44(10-11):930-2. doi: 10.1016/j.clinbiochem.2011.04.017. Epub 2011 May 5.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Multiple Sclerosis
- Sclerosis
- Physiological Effects of Drugs
- Micronutrients
- Bone Density Conservation Agents
- Calcium-Regulating Hormones and Agents
- Vitamin D
- Cholecalciferol
- Vitamins
- Ergocalciferols
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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