search
Back to results

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

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Vitamin D3
Vitamin D3
Sponsored by
University of Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, Vitamin D, Safety

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • St. Michael's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Treatment

Control

Arm Description

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.

Patients are allowed to supplement with up to 4,000 IU per day of Vitamin D3 if desired.

Outcomes

Primary Outcome Measures

Serum calcium

Secondary Outcome Measures

Serum 25(OH)D
EDSS
N-telopeptide (bone marker)
ALP/AST/ALT
Creatinine/urea
EKG
Renal ultrasound
Cytokine profile/MMP/lymphocyte response assay
Annualized relapse rate
PTH

Full Information

First Posted
March 24, 2008
Last Updated
March 27, 2008
Sponsor
University of Toronto
Collaborators
Direct MS-Proactive Charity, Multiple Sclerosis Society of Canada
search

1. Study Identification

Unique Protocol Identification Number
NCT00644904
Brief Title
Safety Trial of High Dose Oral Vitamin D3 With Calcium in Multiple Sclerosis
Acronym
VitD4MS
Official Title
A Phase I/II Dose-Escalation Trial of Vitamin D3 With Calcium Supplementation in Patients With Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Toronto
Collaborators
Direct MS-Proactive Charity, Multiple Sclerosis Society of Canada

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple Sclerosis, Vitamin D, Safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Other
Arm Description
Patients are allowed to supplement with up to 4,000 IU per day of Vitamin D3 if desired.
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D3
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D3
Primary Outcome Measure Information:
Title
Serum calcium
Time Frame
at each dose change
Secondary Outcome Measure Information:
Title
Serum 25(OH)D
Time Frame
at each dose change
Title
EDSS
Time Frame
at screening vs. end of trial
Title
N-telopeptide (bone marker)
Title
ALP/AST/ALT
Time Frame
at each dose change
Title
Creatinine/urea
Time Frame
at each dose change
Title
EKG
Time Frame
at screening and end of trial
Title
Renal ultrasound
Time Frame
at screening, mid-trial and end of trial
Title
Cytokine profile/MMP/lymphocyte response assay
Title
Annualized relapse rate
Time Frame
year prior to trial versus year of trial
Title
PTH
Time Frame
at each dose change

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jodie M Burton, MD
Organizational Affiliation
St. Michael's Hospital, University of Toronto
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paul W O'Connor, MD, MSc
Organizational Affiliation
St. Michael's Hospital, University of Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
17823429
Citation
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.
Results Reference
background
PubMed Identifier
21697250
Citation
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.
Results Reference
derived
PubMed Identifier
21570386
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs