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Safety Trial of High Dose Oral Vitamin D3 With Calcium in Multiple Sclerosis (VitD4MS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00644904
Recruitment Status : Completed
First Posted : March 27, 2008
Last Update Posted : March 28, 2008
Direct MS-Proactive Charity
Multiple Sclerosis Society of Canada
Information provided by:
University of Toronto

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 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

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.
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

Primary Outcome Measures :
  1. Serum calcium [ Time Frame: at each dose change ]

Secondary Outcome Measures :
  1. Serum 25(OH)D [ Time Frame: at each dose change ]
  2. EDSS [ Time Frame: at screening vs. end of trial ]
  3. N-telopeptide (bone marker)
  4. ALP/AST/ALT [ Time Frame: at each dose change ]
  5. Creatinine/urea [ Time Frame: at each dose change ]
  6. EKG [ Time Frame: at screening and end of trial ]
  7. Renal ultrasound [ Time Frame: at screening, mid-trial and end of trial ]
  8. Cytokine profile/MMP/lymphocyte response assay
  9. Annualized relapse rate [ Time Frame: year prior to trial versus year of trial ]
  10. PTH [ Time Frame: at each dose change ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

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

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Canada, Ontario
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Sponsors and Collaborators
University of Toronto
Direct MS-Proactive Charity
Multiple Sclerosis Society of Canada
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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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Paul O'Connor, St. Michael's Hospital, Division of Neurology, University of Toronto
ClinicalTrials.gov Identifier: NCT00644904    
Other Study ID Numbers: REB05-147
First Posted: March 27, 2008    Key Record Dates
Last Update Posted: March 28, 2008
Last Verified: March 2008
Keywords provided by University of Toronto:
Multiple Sclerosis
Vitamin D
Additional relevant MeSH terms:
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Multiple Sclerosis
Vitamin D
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents