Can Vitamin D Supplementation Prevent Bone Loss in Persons With Multip

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

CompletedPhase 4MS (type not specified)NCT00785473

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • Cholecalciferol

    Vitamin D receptor agonist

  • Calcium carbonate

What it measured

Main measures

  • Changes in BMD over the 2 year study period comparing treatment and placebo groups

    2 years

Other measures (7)

  • Cytokine expression following vitamin D supplementation

    2 years

    Immune response

  • 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

    Relapses

  • The number of patients without progression of disability judged by EDSS and

    2 years

    Disability progression

  • Reported infections

    2 years

  • Ratings on a fatigue scale

    2 years

    Fatigue

Who could take part

MS (type not specified) · 18 to 50

Show the full criteria

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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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History

    1. Started

      Jan 2008

    2. Main results due

      Apr 2010

    3. Finished

      Apr 2010

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