Effects of three-monthly oral 150,000 IU cholecalciferol supplementation on falls, mobility, and muscle strength in older postmenopausal women: a randomized controlled trial.
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
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
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 |
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.