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

Phase 1

Completed

• Conditions: Multiple Sclerosis
• Interventions: Dietary Supplement: Vitamin D3

• Registration Number: NCT00644904
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Status Verified: 2008-03
• Study First Submitted: 2008-03-24
• Study First Submitted QC: 2008-03-26
• Study First Posted: 2008-03-27
• Last Update Submitted: 2008-03-27
• Last Update Posted: 2008-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

• Clinically definite MS
• Age 18-55
• EDSS 0-6.5

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Vitamin D3	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.
Control	Vitamin D3	Patients are allowed to supplement with up to 4,000 IU per day of Vitamin D3 if desired.

Primary Outcome Measures

Name	Time	Method
Serum calcium	at each dose change

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada