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

This study has been completed.
Sponsor:
Collaborators:
Direct MS-Proactive Charity
Multiple Sclerosis Society of Canada
Information provided by:
University of Toronto
ClinicalTrials.gov Identifier:
NCT00644904
First received: March 24, 2008
Last updated: March 27, 2008
Last verified: March 2008
  Purpose

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 Intervention Phase
Multiple Sclerosis
Dietary Supplement: Vitamin D3
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Toronto:

Primary Outcome Measures:
  • Serum calcium [ Time Frame: at each dose change ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Serum 25(OH)D [ Time Frame: at each dose change ] [ Designated as safety issue: No ]
  • EDSS [ Time Frame: at screening vs. end of trial ] [ Designated as safety issue: No ]
  • N-telopeptide (bone marker) [ Designated as safety issue: No ]
  • ALP/AST/ALT [ Time Frame: at each dose change ] [ Designated as safety issue: Yes ]
  • Creatinine/urea [ Time Frame: at each dose change ] [ Designated as safety issue: Yes ]
  • EKG [ Time Frame: at screening and end of trial ] [ Designated as safety issue: Yes ]
  • Renal ultrasound [ Time Frame: at screening, mid-trial and end of trial ] [ Designated as safety issue: Yes ]
  • Cytokine profile/MMP/lymphocyte response assay [ Designated as safety issue: No ]
  • Annualized relapse rate [ Time Frame: year prior to trial versus year of trial ] [ Designated as safety issue: No ]
  • PTH [ Time Frame: at each dose change ] [ Designated as safety issue: Yes ]

Enrollment: 49
Study Start Date: July 2006
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Control
Patients are allowed to supplement with up to 4,000 IU per day of Vitamin D3 if desired.
Dietary Supplement: Vitamin D3

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00644904

Locations
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
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
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Paul O'Connor, St. Michael's Hospital, Division of Neurology, University of Toronto
ClinicalTrials.gov Identifier: NCT00644904     History of Changes
Other Study ID Numbers: REB05-147
Study First Received: March 24, 2008
Last Updated: March 27, 2008
Health Authority: Canada: Health Canada

Keywords provided by University of Toronto:
Multiple Sclerosis
Vitamin D
Safety

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on July 23, 2014