(13-04-10) Once-weekly dose of 8400 IU vitamin D3 compared with placebo:

effects on neuromuscular function and tolerability in older adults with vitamin D insufficiency1,2,3



Paul Lips, Neil Binkley, Michael Pfeifer, Robert Recker, Suvajit Samanta, Dosinda A Cohn, Julie Chandler, Elizabeth Rosenberg and Dimitris A Papanicolaou

1 From the Department of Endocrinology Vrije Universiteit Medisch Centrum Amsterdam Netherlands (PL); the Department of Osteoporosis Clinical Research University of Wisconsin Madison WI (NB); Klinik der Furstenhof Bad Pyrmont Germany (MP); the Osteoporosis Research Center Creighton University Omaha NE (RR); Merck & Co Inc Rahway NJ (SS DAC JCDAP);Merck & Co Inc North Wales PA (ER).
2 Supported by Merck & Co Inc.
3 Address correspondence to P Lips, Department of Endocrinology, Vrije Universiteit Medisch Centrum, PO Box 7057, Amsterdam 1007 MB, Netherlands. E-mail: [email protected] .
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 D3 on postural stability, muscle strength, and safety.
Design: In this double-blind trial, subjects aged 70 y with serum 25-hydroxyvitamin D [25(OH)D] concentrations 20 but 6 ng/mL were randomly assigned to receive a weekly dose of 8400 IU vitamin D3 (n = 114) or a placebo (n = 112). Mediolateral body sway with eyes open (assessed with the AccuSwayPLUS 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 D3 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 ( 0.46 compared with <0.46 cm), treatment with 8400 IU vitamin D3 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 D3, but not in placebo-treated patients, parathyroid hormone decreased significantly.
Conclusions: Weekly treatment with 8400 IU vitamin D3 raised 25(OH)D concentrations in elderly, vitamin D?insufficient individuals. Treatment with 8400 IU vitamin D3 did not reduce mediolateral sway significantly compared with treatment with placebo in this population, although in post hoc analysis, treatment with 8400 IU vitamin D3 reduced sway in the subgroup of patients who had elevated sway at baseline. Weekly treatment with 8400 IU vitamin D3 was well tolerated. This trial was registered at clinicaltrials.gov as NCT00242476.

Source: Am J Clin Nutr 91: 985-991, 2010

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