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

University Hospital of North Norway

Status and phase

Completed

Phase 4

Conditions

Multiple Sclerosis, Osteoporosis

Treatments

Dietary Supplement: calcium carbonate

Dietary Supplement: cholecalciferol

Study type

Interventional

Funder types

Other

Identifiers

NCT00785473

MSvitD1

EudraCT 2006-00427-11

Details and patient eligibility

About

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.

Enrollment

80 estimated patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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.