NCT00785473

Can Vitamin D Supplementation Prevent Bone Loss in Persons With Multiple Sclerosis

Can Vitamin D Supplementation Prevent Bone Loss in Persons With MS? A Randomised, Placebo-controlled, Single-centre Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: University Hospital of North Norway · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

Several studies have shown that bone mineral density (BMD) at the femoral neck decreases with increasing physical handicap (EDSS-score) in MS patients. Possible explanations are less weightbearing exercise or less UV-exposure resulting in reduced vitamin D generation in the skin. Prevention of osteoporosis is a high priority, because treatment of the established disease remains sub-optimal. We have designed a double-blind randomised controlled trial of two years' duration including 90-100 persons with MS age 18-50 to assess whether supplementation with vitamin D, given as a weekly dose of 20,000 IU cholecalciferol, can prevent bone loss. The primary objective of this study is to determine changes in BMD over the 2 year study period comparing treatment and placebo groups. The most important secondary objective is to determine cytokine profiles in blood samples. We will also assess parameters related to vitamin D status and physical performance.

Conditions

• Multiple Sclerosis, Osteoporosis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	cholecalciferol	cholecalciferol capsules, 20,000 IU weekly for 2 years and calcium carbonate 500 mg daily
DIETARY_SUPPLEMENT	calcium carbonate	calcium carbonate 500 mg daily for 2 years

Timeline

• Start date: 2008-01-01
• Primary completion: 2010-04-01
• Completion: 2010-04-01
• First posted: 2008-11-05
• Last updated: 2011-09-05

Locations

1 site across 1 country: Norway