Multiple Sclerosis, Osteoporosis Clinical Trial
Official title:
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention