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Can vitamin D supplementation prevent bone loss in persons with MS? A placebo-controlled trial.

Journal of neurology
September 1, 2011
Linn H Steffensen et al. (5 authors)
Clinical Trial, Phase IIJournal ArticleRandomized Controlled TrialResearch Support, Non-U.S. Gov'tHuman StudyClinical
Study Details

Study Goal

The researchers aimed to determine whether weekly high-dose vitamin D3 (20,000 IU) combined with daily calcium (500 mg) could prevent bone loss in ambulatory persons with multiple sclerosis (MS).

Results Summary

The study found no significant difference in bone mineral density (BMD) changes between the vitamin D3/calcium group and the placebo group after 96 weeks. BMD decreased slightly in both groups, with no statistically meaningful benefit from the intervention.

Population

Ambulatory persons with MS aged 18-50 years.

Effective Dosage

500 mg calcium daily.

Duration

96 weeks.

Interactions

None mentioned.

Extracted Claims (5)
InterventionDirectionEndpointPopulationDosageImpactClaim #
20,000 IU vitamin D(3) once a week and 500 mg calcium daily
no change
bone loss
ambulatory persons with MS age 18-50 years
no significant change
did not prevent
#1
20,000 IU vitamin D(3) once a week
increase
serum 25-hydroxyvitamin D [25(OH)D] levels
intervention group
from 55 nmol/L at baseline to 123 nmol/L at week 96
increased
#2
20,000 IU vitamin D(3) once a week and 500 mg calcium daily
no change
percentage change in bone mineral density (BMD) at the hip, the spine, and the ultradistral radius
participants
-
did not differ
#3
placebo once a week and 500 mg calcium daily
decrease
BMD at the hip
placebo group
by 1.4%
decreased
#4
20,000 IU vitamin D(3) once a week and 500 mg calcium daily
decrease
BMD at the hip
treatment group
by 0.7%
decreased
#5
Abstract

Multiple sclerosis (MS) is a possible cause of secondary osteoporosis. In this phase II trial we assessed whether a weekly dose of 20,000 IU vitamin D(3) prevents bone loss in ambulatory persons with MS age 18-50 years. ClinicalTrials.gov ID NCT00785473. All patients managed at the University Hospital of North Norway who fulfilled the main inclusion criteria were invited to participate in this double-blinded trial. Participants were randomised to receive 20,000 IU vitamin D(3) or placebo once a week and 500 mg calcium daily for 96 weeks. The primary outcome was the effect of the intervention on percentage change in bone mineral density (BMD) at the hip, the spine, and the ultradistal radius over the study period. Of 71 participants randomised, 68 completed. Mean serum 25-hydroxyvitamin D [25(OH)D] levels in the intervention group increased from 55 nmol/L at baseline to 123 nmol/L at week 96. After 96 weeks, percentage change in BMD did not differ between groups at any site. BMD decreased at the hip, by 1.4% in the placebo group (95% CI -2.3 to -0.4, SD 2.7, p = 0.006) and by 0.7% in the treatment group (-1.6 to 0.2, 2.7, p = 0.118), difference 0.7% (-1.9 to 0.7, p = 0.332). Findings were not altered by adjustment for sex or serum 25(OH)D. Supplementation with 20,000 IU vitamin D(3) a week did not prevent bone loss in this small population. Larger studies are warranted to assess the effect of vitamin D on bone health in persons with MS.

Medical Subject Headings (MeSH)
AdultBone Density Conservation AgentsCholecalciferolDietary SupplementsDouble-Blind MethodFemaleHumansMaleMiddle AgedMultiple SclerosisOsteoporosisPlacebosYoung Adult
Study Links
Quality Scores
SafetyNot Assessed
Efficacy30/10
Quality75/10
Citation Metrics
Total Citations43
Citations/Year3.1
Relative Citation Ratio1.33
NIH Percentile60.8%
Research Impact Scores
APT Score0.75
Weight Score1.36
Normalized Score0.47
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Can vitamin D supplementation prevent bone loss in persons w... | Panacea Index