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.
| Status | Completed |
| Enrollment | 80 |
| Est. completion date | April 2010 |
| Est. primary completion date | April 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 50 Years |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Norway | University Hospital of North Norway | Tromsø |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital of North Norway |
Norway,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Changes in BMD over the 2 year study period comparing treatment and placebo groups | 2 years | No | |
| Secondary | Cytokine expression following vitamin D supplementation | 2 years | No | |
| Secondary | 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 | No | |
| Secondary | Changes in parameters of lower extremity function over the 2 year study period | 2 years | No | |
| Secondary | The number of relapses, the time to first relapse, the number of relapse-free patients | 2 years | No | |
| Secondary | The number of patients without progression of disability judged by EDSS and | 2 years | No | |
| Secondary | Reported infections | 2 years | No | |
| Secondary | Ratings on a fatigue scale | 2 years | No |