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Effect of isolated vitamin D supplementation on the rate of falls and postural balance in postmenopausal women fallers: a randomized, double-blind, placebo-controlled trial

Cangussu, Luciana Mendes MSc; Nahas-Neto, Jorge MD, PhD; Orsatti, Claudio Lera PhD; Poloni, Priscila Ferreira MD; Schmitt, Eneida Boteon MD; Almeida-Filho, Benedito MD; Nahas, Eliana Aguiar Petri MD, PhD

doi: 10.1097/GME.0000000000000525
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Objective: To evaluate the effect of isolated vitamin D supplementation (VITD) on the rate of falls and postural balance in postmenopausal women fallers.

Methods: In this double-blind, placebo-controlled trial, 160 Brazilian younger postmenopausal women were randomized into two groups: VITD group, vitamin D3 supplementation 1,000 IU/day/orally (n = 80) and placebo group (n = 80). Women with amenorrhea at least 12 months, age 50 to 65 years, and a history of falls (previous 12 months) were included. Those with neurological or musculoskeletal disorders, vestibulopathies, drugs use that could affect balance and osteoporosis were excluded. The intervention time was 9 months. Postural balance was assessed by stabilometry (computerized force platform) and investigation on the occurrence/recurrence of falls was performed by interviews. The plasma concentration of 25-hydroxyvitamin D [25(OH)D] was measured by high-performance liquid chromatography. Statistical analysis was achieved by intention-to-treat, using analysis of variance, Student's t test, Tukey test, chi-square, and logistic regression.

Results: After 9 months, mean values of 25(OH)D increased from 15.0 ± 7.5 ng/mL to 27.5 ± 10.4 ng/mL (+45.4%) in the VITD group, and decreased from 16.9 ± 6.7 ng/mL to 13.8 ± 6.0 ng/mL (−18.5%) in the placebo group (P < 0.001). The occurrence of falls was higher in the placebo group (+46.3%) with an adjusted risk of 1.95 (95% confidence interval [CI] 1.23-3.08) times more likely to fall and 2.80 (95% CI 1.43-5.50) times higher for recurrent falls compared to the VITD group (P < 0.001). There was reduction in body sway by stabilometry, with lower amplitude of antero-posterior (−35.5%) and latero-lateral (−37.0%) oscillation, only in the VITD group (P < 0.001).

Conclusions: In Brazilian postmenopausal women fallers, isolated vitamin D supplementation for 9 months resulted in a lower incidence of falls and improvement in postural balance.

Department of Gynecology and Obstetrics, Botucatu Medical School, Sao Paulo State University—UNESP, Sao Paulo, Brazil.

Address correspondence to: Eliana Aguiar Petri Nahas, MD, PhD, Department of Gynecology and Obstetrics, Botucatu Medical School, Sao Paulo State University—UNESP, Distrito de Rubião Júnior s/n, ZIP18618-970, Botucatu, SP, Brazil. E-mail: epetri@fmb.unesp.br

Received 7 April, 2015

Revised 16 June, 2015

Accepted 16 June, 2015

The authors have no commercial, proprietary, or financial interest in the products or instruments described in this article.

The study was registered at and approved by the Brazilian Clinical Trials Registry under the registration number RBR-222wfk.

Funding/support: This study was supported by the Sao Paulo Research Foundation (FAPESP; grant number 2011/14447-1).

Financial disclosure/conflicts of interest: None reported.

© 2016 by The North American Menopause Society.