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

Sponsor

University of Toronto (Other)

Overall Status

Completed

CT.gov ID

NCT00644904

Collaborator

Direct MS-Proactive Charity (Other), Multiple Sclerosis Society of Canada (Other)

Enrollment

Location

Arms

19.1

Duration (Months)

2.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis	Dietary Supplement: Vitamin D3 Dietary Supplement: Vitamin D3	Phase 1/Phase 2

Study Design

Study Type:

Interventional

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 :

Jul 1, 2006

Actual Primary Completion Date :

Feb 1, 2008

Actual Study Completion Date :

Feb 1, 2008

Arms and Interventions

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
Other: Control Patients are allowed to supplement with up to 4,000 IU per day of Vitamin D3 if desired.	Dietary Supplement: Vitamin D3

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

Other: Control

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

Dietary Supplement: Vitamin D3

Outcome Measures

Primary Outcome Measures

Serum calcium [at each dose change]

Secondary Outcome Measures

Serum 25(OH)D [at each dose change]
EDSS [at screening vs. end of trial]
N-telopeptide (bone marker) []
ALP/AST/ALT [at each dose change]
Creatinine/urea [at each dose change]
EKG [at screening and end of trial]
Renal ultrasound [at screening, mid-trial and end of trial]
Cytokine profile/MMP/lymphocyte response assay []
Annualized relapse rate [year prior to trial versus year of trial]
PTH [at each dose change]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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