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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
80
cholecalciferol capsules, 20,000 IU weekly for 2 years and calcium carbonate 500 mg daily
calcium carbonate 500 mg daily for 2 years
University Hospital of North Norway
Tromsø, Norway
Changes in BMD over the 2 year study period comparing treatment and placebo groups
Time frame: 2 years
Cytokine expression following vitamin D supplementation
Time frame: 2 years
Contribution of vitamin D from different sources (generation in the skin, diet and supplements) to serum 25(OH) vitamin D (vitamin D status)
Time frame: 2 years
Changes in parameters of lower extremity function over the 2 year study period
Time frame: 2 years
The number of relapses, the time to first relapse, the number of relapse-free patients
Time frame: 2 years
The number of patients without progression of disability judged by EDSS and
Time frame: 2 years
Reported infections
Time frame: 2 years
Ratings on a fatigue scale
Time frame: 2 years
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