Status:
COMPLETED
Can Vitamin D Supplementation Prevent Bone Loss in Persons With Multiple Sclerosis
Lead Sponsor:
University Hospital of North Norway
Conditions:
Multiple Sclerosis, Osteoporosis
Eligibility:
All Genders
18-50 years
Phase:
PHASE4
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 exe...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2010
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00785473
Start Date
January 1 2008
End Date
April 1 2010
Last Update
September 5 2011
Active Locations (1)
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1
University Hospital of North Norway
Tromsø, Norway, 9038