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Can Vitamin D Supplementation Prevent Bone Loss in Persons With MS? A Randomised, Placebo-controlled, Single-centre Study
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.
Age
18 - 50 years
Sex
ALL
Healthy Volunteers
No
University Hospital of North Norway
Tromsø, Norway
Start Date
January 1, 2008
Primary Completion Date
April 1, 2010
Completion Date
April 1, 2010
Last Updated
September 5, 2011
80
ESTIMATED participants
cholecalciferol
DIETARY_SUPPLEMENT
calcium carbonate
DIETARY_SUPPLEMENT
Lead Sponsor
University Hospital of North Norway
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