Once-weekly dose of 8400 IU vitamin D(3) compared with placebo: effects on neuromuscular function and tolerability in older adults with vitamin D insufficiency.
BACKGROUND
Vitamin D insufficiency, which is prevalent in older individuals, is associated with bone and muscle weakness and falls.


OBJECTIVE
We examined the effects of a weekly dose of 8400 IU vitamin D(3) on postural stability, muscle strength, and safety.


METHODS
In this double-blind trial, subjects aged > or =70 y with serum 25-hydroxyvitamin D [25(OH)D] concentrations < or =20 but > or =6 ng/mL were randomly assigned to receive a weekly dose of 8400 IU vitamin D(3) (n = 114) or a placebo (n = 112). Mediolateral body sway with eyes open (assessed with the AccuSway(PLUS) platform; Advanced Medical Technology Inc, Watertown, MA) was the primary endpoint. Secondary endpoints included the short physical performance battery (SPPB) and serum 25(OH)D concentrations. An analysis of covariance model was used for treatment comparisons. Safety and tolerability were monitored.


RESULTS
Serum 25(OH)D concentrations rose significantly (from 13.9 to 26.2 ng/mL, P < 0.001) in patients treated with 8400 IU vitamin D(3) but not in patients treated with the placebo. After 16 wk, neither mediolateral sway nor SPPB differed significantly between treatment groups. However, in the post hoc analysis of patients subgrouped by baseline sway (> or = 0.46 compared with <0.46 cm), treatment with 8400 IU vitamin D(3) significantly reduced sway compared with treatment with placebo (P = 0.047) in patients with elevated baseline sway but not in patients with normal baseline sway. Adverse experiences and incidences of hypercalcemia, hypercalciuria, and elevated creatinine were similar with both treatments. In patients treated with 8400 IU vitamin D(3), but not in placebo-treated patients, parathyroid hormone decreased significantly.


CONCLUSIONS
Weekly treatment with 8400 IU vitamin D(3) raised 25(OH)D concentrations in elderly, vitamin D-insufficient individuals. Treatment with 8400 IU vitamin D(3) did not reduce mediolateral sway significantly compared with treatment with placebo in this population, although in post hoc analysis, treatment with 8400 IU vitamin D(3) reduced sway in the subgroup of patients who had elevated sway at baseline. Weekly treatment with 8400 IU vitamin D(3) was well tolerated. This trial was registered at clinicaltrials.gov as NCT00242476.
Lips
Paul
P
Department of Endocrinology, Vrije Universiteit Medisch Centrum, Amsterdam, The Netherlands. p.lips@vumc.nl
Binkley
Neil
N
Pfeifer
Michael
M
Recker
Robert
R
Samanta
Suvajit
S
Cohn
Dosinda A
DA
Chandler
Julie
J
Rosenberg
Elizabeth
E
Papanicolaou
Dimitris A
DA
D000368:Aged; D000369:Aged, 80 and over; D002762:Cholecalciferol / Q000008:administration & dosage*; D019587:Dietary Supplements; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D009068:Movement / Q000187:drug effects*; D010281:Parathyroid Hormone / Q000097:blood*; D004856:Postural Balance / Q000187:drug effects*; D014807:Vitamin D / Q000031:analogs & derivatives* / Q000097:blood; D014808:Vitamin D Deficiency / Q000097:blood / Q000188:drug therapy* / Q000503:physiopathology; D014815:Vitamins / Q000009:adverse effects / Q000097:blood / Q000494:pharmacology*
D010281:Parathyroid Hormone; D014815:Vitamins; D014807:Vitamin D; D002762:Cholecalciferol; C104450:25-hydroxyvitamin D