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

Phase 4

Completed

• Conditions: Multiple Sclerosis, Osteoporosis
• Interventions: Dietary Supplement: cholecalciferol; Dietary Supplement: calcium carbonate

• Registration Number: NCT00785473
• Lead Sponsor: University Hospital of North Norway

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-11-04
• Study First Submitted QC: 2008-11-04
• Study First Posted: 2008-11-05
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-02
• Last Update Posted: 2011-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	cholecalciferol	cholecalciferol, calcium carbonate
1	calcium carbonate	cholecalciferol, calcium carbonate
2	calcium carbonate	capsules not containing cholecalciferol, otherwise identical to Active comparator; calcium carbonate

Primary Outcome Measures

Name	Time	Method
Changes in BMD over the 2 year study period comparing treatment and placebo groups	2 years

Secondary Outcome Measures

Name	Time	Method
Ratings on a fatigue scale	2 years
The number of patients without progression of disability judged by EDSS and	2 years
Reported infections	2 years
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

Trial Locations

Locations (1)

University Hospital of North Norway; 🇳🇴 Tromsø, Norway