Multiple Sclerosis, Osteoporosis
Conditions
Brief 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.
Interventions
DIETARY_SUPPLEMENTcholecalciferol
cholecalciferol capsules, 20,000 IU weekly for 2 years and calcium carbonate 500 mg daily
DIETARY_SUPPLEMENTcalcium carbonate
calcium carbonate 500 mg daily for 2 years
Sponsors
University Hospital of North Norway
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Age 18 to 50 years * EDSS \< 4.0 (able to walk without rest some 500 m) * Women have to be premenopausal * MS according to the McDonald criteria; prepared and considered able to follow the protocol; using appropriate contraceptive methods (women of childbearing potential) * Having given written informed consent.
Exclusion criteria
* Pregnancy or unwillingness to use contraception; alcohol or drug abuse * Use of glucocorticoid treatment other than intravenous methylprednisolone for treatment of relapses * Known allergy to cholecalciferol or arachis oil (peanuts) * Therapy with digitalis, calcitonin, active vitamin D3 analogues, fluoride, or bisphosphonates during the previous 12 months * Any condition predisposing to hypercalcaemia * Nephrolithiasis or renal insufficiency * Presence of primary hyperparathyroidism, hyperthyroidism, or hypothyroidism in the year before the study began; a history of nephrolithiasis during the previous five years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in BMD over the 2 year study period comparing treatment and placebo groups | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Contribution of vitamin D from different sources (generation in the skin, diet and supplements) to serum 25(OH) vitamin D (vitamin D status) | 2 years |
| Changes in parameters of lower extremity function over the 2 year study period | 2 years |
| The number of relapses, the time to first relapse, the number of relapse-free patients | 2 years |
| Cytokine expression following vitamin D supplementation | 2 years |
| Reported infections | 2 years |
| Ratings on a fatigue scale | 2 years |
| The number of patients without progression of disability judged by EDSS and | 2 years |
Countries
Norway
Outcome results
None listed