Clinical trial NCT00785473: Can Vitamin D Supplementation Prevent Bone Loss in Persons With Multiple Sclerosis
Official title: Can Vitamin D Supplementation Prevent Bone Loss in Persons With MS? A Randomised, Placebo-controlled, Single-centre Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Multiple Sclerosis, Osteoporosis
Lead sponsor: University Hospital of North Norway
Sponsor class: OTHER
First posted: 2008-11-05
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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.

Primary outcomes:
measure: Changes in BMD over the 2 year study period comparing treatment and placebo groups
timeFrame: 2 years
Secondary outcomes:
measure: Cytokine expression following vitamin D supplementation
timeFrame: 2 years
measure: Contribution of vitamin D from different sources (generation in the skin, diet and supplements) to serum 25(OH) vitamin D (vitamin D status)
timeFrame: 2 years
measure: Changes in parameters of lower extremity function over the 2 year study period
timeFrame: 2 years
measure: The number of relapses, the time to first relapse, the number of relapse-free patients
timeFrame: 2 years
measure: The number of patients without progression of disability judged by EDSS and
timeFrame: 2 years
measure: Reported infections
timeFrame: 2 years
measure: Ratings on a fatigue scale
timeFrame: 2 years
Other outcomes:
Locations:
city: Tromsø
country: Norway
facility: University Hospital of North Norway
Study officials:
affiliation: University Hospital of North Norway
name: Margitta T Kampman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Holmoy T, Lindstrom JC, Eriksen EF, Steffensen LH, Kampman MT. High dose vitamin D supplementation does not affect biochemical bone markers in multiple sclerosis - a randomized controlled trial. BMC Neurol. 2017 Apr 4;17(1):67. doi: 10.1186/s12883-017-0851-0.
citation: Rosjo E, Lossius A, Abdelmagid N, Lindstrom JC, Kampman MT, Jorgensen L, Sundstrom P, Olsson T, Steffensen LH, Torkildsen O, Holmoy T. Effect of high-dose vitamin D3 supplementation on antibody responses against Epstein-Barr virus in relapsing-remitting multiple sclerosis. Mult Scler. 2017 Mar;23(3):395-402. doi: 10.1177/1352458516654310. Epub 2016 Jul 11.
citation: Kampman MT, Steffensen LH, Mellgren SI, Jorgensen L. Effect of vitamin D3 supplementation on relapses, disease progression, and measures of function in persons with multiple sclerosis: exploratory outcomes from a double-blind randomised controlled trial. Mult Scler. 2012 Aug;18(8):1144-51. doi: 10.1177/1352458511434607. Epub 2012 Feb 21.
citation: Steffensen LH, Jorgensen L, Straume B, Mellgren SI, Kampman MT. Can vitamin D supplementation prevent bone loss in persons with MS? A placebo-controlled trial. J Neurol. 2011 Sep;258(9):1624-31. doi: 10.1007/s00415-011-5980-6. Epub 2011 Mar 13.