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Effects of three-monthly oral 150,000 IU cholecalciferol supplementation on falls, mobility, and muscle strength in older postmenopausal women: a randomized controlled trial.

Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research
January 1, 2012
Paul Glendenning et al. (6 authors)
Journal ArticleRandomized Controlled TrialResearch Support, Non-U.S. Gov'tHuman StudyClinical
Study Details

Study Goal

The researchers aimed to determine whether supervised oral 3-monthly vitamin D therapy, alongside calcium supplementation, reduces falls, improves muscle strength, and enhances mobility in older women.

Results Summary

The study found that intermittent high-dose vitamin D (150,000 IU every 3 months) had no beneficial or adverse effects on falls, muscle strength, or mobility compared to placebo, despite higher serum 25OHD levels in the treatment group. Calcium intake remained stable, and fall rates did not differ between groups.

Population

Community-dwelling ambulant women aged over 70 years (mean age 76.7 ± 4.1 years).

Effective Dosage

Participants were advised to increase dietary calcium intake, but no specific calcium dosage was provided.

Duration

9 months

Interactions

None mentioned

Extracted Claims (9)
InterventionDirectionEndpointPopulationDosageImpactClaim #
Daily vitamin D in addition to calcium supplementation
decrease
falls and fractures
older women
-
reduces
#1
supervised oral 3-monthly vitamin D therapy
neutral
falls, muscle strength, and mobility
686 community-dwelling ambulant women aged over 70 years
-
To examine the effects
#2
oral cholecalciferol 150,000 IU every 3 months
increase
25OHD levels
vitamin D group
15 nmol/L
were approximately 15 nmol/L higher
#3
Calcium intake
no change
Calcium intake
All participants
-
did not change significantly
#4
oral cholecalciferol 150,000 IU every 3 months
no change
Faller rates
vitamin D group vs placebo group
-
Faller rates in the two groups did not differ
#5
vitamin D
no change
muscle strength, and TUG
-
-
were not altered
#6
oral cholecalciferol 150,000 IU therapy administered 3-monthly
no change
falls or physical function
-
-
had neither beneficial nor adverse effects
#7
intermittent large doses of vitamin D
no change
falls
-
-
are ineffective or have a deleterious effect
#8
an intermittent, high-dose vitamin D regimen
no change
falls and fractures
-
-
cannot be supported as a strategy to reduce
#9
Abstract

Daily vitamin D in addition to calcium supplementation reduces falls and fractures in older women. However, poor adherence to therapy is a common clinical problem. To examine the effects of supervised oral 3-monthly vitamin D therapy on falls, muscle strength, and mobility, we conducted a 9-month randomized, double-blind, placebo-controlled trial in 686 community-dwelling ambulant women aged over 70 years. Participants received either oral cholecalciferol 150,000 IU every 3 months (n = 353) or an identical placebo (n = 333). All participants were advised to increase dietary calcium intake. Falls data were collected 3-monthly. At baseline, 3, 6, and 9 months, muscle strength was measured by a handheld dynamometer and mobility by the Timed Up and Go (TUG) test. Serum 25 hydroxyvitamin D (25OHD) was measured in a subgroup of 40 subjects. Mean age at baseline was 76.7 ± 4.1 years. The average serum 25OHD value at baseline was 65.8 ± 22.7 nmol/L. By 3, 6, and 9 months after supplementation, 25OHD levels of the vitamin D group were approximately 15 nmol/L higher than the placebo group. Calcium intake did not change significantly between baseline (864 ± 412 mg/day) and 9 months (855 ± 357 mg/day). Faller rates in the two groups did not differ: vitamin D group, 102 of 353 (29%); placebo group, 89 of 333 (27%). At 9 months, compared to placebo or baseline, muscle strength, and TUG were not altered by vitamin D. In conclusion, oral cholecalciferol 150,000 IU therapy administered 3-monthly had neither beneficial nor adverse effects on falls or physical function. These data together with previous findings confirm that intermittent large doses of vitamin D are ineffective or have a deleterious effect on falls. Thus despite adherence issues with daily vitamin D replacement, an intermittent, high-dose vitamin D regimen cannot be supported as a strategy to reduce falls and fractures.

Medical Subject Headings (MeSH)
Accidental FallsAdministration, OralAgedCalciumCholecalciferolDietary SupplementsDrug Administration ScheduleFemaleHumansLife StyleMovementMuscle StrengthPostmenopauseVitamin D
Study Links
Quality Scores
SafetyNot Assessed
Efficacy20/10
Quality85/10
Citation Metrics
Total Citations106
Citations/Year8.2
Relative Citation Ratio4.01
NIH Percentile90.2%
Research Impact Scores
APT Score0.95
Weight Score1.67
Normalized Score0.45
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