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Trial record 2 of 43 for:    "multiple sclerosis" AND "vitamin D"

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
Sponsor:
Collaborators:
Direct MS-Proactive Charity
Multiple Sclerosis Society of Canada
Information provided by:
University of Toronto

Tracking Information
First Submitted Date  ICMJE March 24, 2008
First Posted Date  ICMJE March 27, 2008
Last Update Posted Date March 28, 2008
Study Start Date  ICMJE July 2006
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 26, 2008)
Serum calcium [ Time Frame: at each dose change ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00644904 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 26, 2008)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety Trial of High Dose Oral Vitamin D3 With Calcium in Multiple Sclerosis
Official Title  ICMJE A Phase I/II Dose-Escalation Trial of Vitamin D3 With Calcium Supplementation in Patients With Multiple Sclerosis
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Multiple Sclerosis
Intervention  ICMJE Dietary Supplement: Vitamin D3
Study Arms  ICMJE
  • 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.
    Intervention: Dietary Supplement: Vitamin D3
  • Control
    Patients are allowed to supplement with up to 4,000 IU per day of Vitamin D3 if desired.
    Intervention: Dietary Supplement: Vitamin D3
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 26, 2008)
49
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2008
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00644904
Other Study ID Numbers  ICMJE REB05-147
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Paul O'Connor, St. Michael's Hospital, Division of Neurology, University of Toronto
Study Sponsor  ICMJE University of Toronto
Collaborators  ICMJE
  • Direct MS-Proactive Charity
  • Multiple Sclerosis Society of Canada
Investigators  ICMJE
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
PRS Account University of Toronto
Verification Date March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP