title: Effects of three-monthly oral 150,000 IU cholecalciferol supplementation on falls, mobility, and muscle strength in older postmenopausal women: a randomized controlled trial.
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.
authors.affiliation: School of Medicine and Pharmacology, University of Western Australia, Perth, Australia.
authors.forename: Paul
authors.initials: P
authors.lastname: Glendenning
authors.forename: Kun
authors.initials: K
authors.lastname: Zhu
authors.forename: Charles
authors.initials: C
authors.lastname: Inderjeeth
authors.forename: Peter
authors.initials: P
authors.lastname: Howat
authors.forename: Joshua R
authors.initials: JR
authors.lastname: Lewis
authors.forename: Richard L
authors.initials: RL
authors.lastname: Prince
mesh_terms: D000058:Accidental Falls / Q000517:prevention & control*; D000284:Administration, Oral; D000368:Aged; D002118:Calcium / Q000008:administration & dosage / Q000494:pharmacology; D002762:Cholecalciferol / Q000008:administration & dosage* / Q000009:adverse effects / Q000494:pharmacology*; D019587:Dietary Supplements; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008019:Life Style; D009068:Movement / Q000187:drug effects*; D053580:Muscle Strength / Q000187:drug effects*; D017698:Postmenopause / Q000097:blood / Q000187:drug effects* / Q000502:physiology; D014807:Vitamin D / Q000031:analogs & derivatives / Q000097:blood
chemical_list: D014807:Vitamin D; D002762:Cholecalciferol; C104450:25-hydroxyvitamin D; D002118:Calcium