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

Study Overview
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Brief Summary
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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.

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

Conditions
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Multiple Sclerosis, Osteoporosis

Intervention / Treatment
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* Dietary Supplement: cholecalciferol
* Dietary Supplement: calcium carbonate


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>cholecalciferol, calcium carbonate | Dietary Supplement: cholecalciferol<br>* cholecalciferol capsules, 20,000 IU weekly for 2 years and calcium carbonate 500 mg daily<br>* Other names: Dekristol, Weifa-kalsium;Dietary Supplement: calcium carbonate<br>* calcium carbonate 500 mg daily for 2 years<br>* Other names: Weifa-kalsium;|
| Placebo Comparator: 2<br>capsules not containing cholecalciferol, otherwise identical to Active comparator; calcium carbonate | Dietary Supplement: calcium carbonate<br>* calcium carbonate 500 mg daily for 2 years<br>* Other names: Weifa-kalsium;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in BMD over the 2 year study period comparing treatment and placebo groups |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cytokine expression following vitamin D supplementation |  | 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) |  | 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 | 
| The number of patients without progression of disability judged by EDSS and |  | 2 years | 
| Reported infections |  | 2 years | 
| Ratings on a fatigue scale |  | 2 years |