Trial | NCT00644904  Report issue

Title

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

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    vitamin d3 ...

  • Study Participants

    49
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.
Study Started
Jul 31
2006
Primary Completion
Feb 29
2008
Study Completion
Feb 29
2008
Last Update
Mar 28
2008
Estimate

Dietary Supplement Vitamin D3

Dietary Supplement Vitamin D3

Treatment Experimental

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 Other

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

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
No Results Posted