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

Multiple Sclerosis Clinical Trial

— VitD4MS  

Official title:

A Phase I/II Dose-Escalation Trial of Vitamin D3 With Calcium Supplementation in Patients With Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00644904
• Other study ID #: REB05-147
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 24, 2008
• Last updated: March 27, 2008
• Start date: July 2006
• Est. completion date: February 2008

Study information

• Verified date: March 2008
• Source: University of Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Dietary Supplement:
• Vitamin D3

• Vitamin D3

Locations

Country	Name	City	State
Canada	St. Michael's Hospital	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
University of Toronto	Direct MS-Proactive Charity, Multiple Sclerosis Society of Canada

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum calcium		at each dose change	Yes
Secondary	Serum 25(OH)D		at each dose change	No
Secondary	EDSS		at screening vs. end of trial	No
Secondary	N-telopeptide (bone marker)			No
Secondary	ALP/AST/ALT		at each dose change	Yes
Secondary	Creatinine/urea		at each dose change	Yes
Secondary	EKG		at screening and end of trial	Yes
Secondary	Renal ultrasound		at screening, mid-trial and end of trial	Yes
Secondary	Cytokine profile/MMP/lymphocyte response assay			No
Secondary	Annualized relapse rate		year prior to trial versus year of trial	No
Secondary	PTH		at each dose change	Yes