Vitamin D supplementation to prevent depression and poor physical function in older adults: Study protocol of the D-Vitaal study, a randomized placebo-controlled clinical trial

BMC Geriatrics

Study Protocol

Annemieke C. Heijboer¹  Pierre M. Bet²  Martin den Heijer³  Natasja M. van Schoor⁴  Elisa J. de Koning⁴  Petra J.M. Elders⁵  Harm W.J. van Marwijk⁶  Maurits W. van Tulder⁷  Paul Lips⁸  Brenda W.J.H. Penninx⁹  Jan. H. Smit⁹ 

[1] Department of Clinical Chemistry, Endocrine Laboratory, VU University Medical Center, P.O. Box 7057, 1007 MB, Amsterdam, The Netherlands;Department of Clinical Pharmacology and Pharmacy, VU University Medical Center, P.O. Box 7057, 1007 MB, Amsterdam, The Netherlands;Department of Internal Medicine, Endocrine section, VU University Medical Center, P.O. Box 7057, 1007 MB, Amsterdam, The Netherlands;EMGO Institute for Health and Care Research, VU University Medical Center, P.O. Box 7057, 1007 MB, Amsterdam, The Netherlands;Department of Epidemiology and Biostatistics, VU University Medical Center, P.O. Box 7057, 1007 MB, Amsterdam, The Netherlands;EMGO Institute for Health and Care Research, VU University Medical Center, P.O. Box 7057, 1007 MB, Amsterdam, The Netherlands;Department of General Practice and Elderly Care Medicine, VU University Medical Center, P.O. Box 7057, 1007 MB, Amsterdam, The Netherlands;EMGO Institute for Health and Care Research, VU University Medical Center, P.O. Box 7057, 1007 MB, Amsterdam, The Netherlands;Department of General Practice and Elderly Care Medicine, VU University Medical Center, P.O. Box 7057, 1007 MB, Amsterdam, The Netherlands;Primary Care Research Centre, Institute of Population Health, University of Manchester, Oxford Road, M13 9PL, Manchester, United Kingdom;EMGO Institute for Health and Care Research, VU University Medical Center, P.O. Box 7057, 1007 MB, Amsterdam, The Netherlands;Department of Health Sciences, VU University, P.O. Box 7057, 1007 MB, Amsterdam, The Netherlands;EMGO Institute for Health and Care Research, VU University Medical Center, P.O. Box 7057, 1007 MB, Amsterdam, The Netherlands;Department of Internal Medicine, Endocrine section, VU University Medical Center, P.O. Box 7057, 1007 MB, Amsterdam, The Netherlands;EMGO Institute for Health and Care Research, VU University Medical Center, P.O. Box 7057, 1007 MB, Amsterdam, The Netherlands;Department of Psychiatry, VU University Medical Center/GGZ inGeest, P.O. Box 1081 HL, A.J. Ernststraat 1187, Amsterdam, The Netherlands;

关键词: Vitamin D;    Depressive symptoms;    Physical functioning;    Functional limitations;    Physical performance;    Older adults;    Randomized clinical trial;    Prevention;    Supplementation;   

DOI  :  10.1186/s12877-015-0148-3

 received in 2015-07-31, accepted in 2015-11-13,  发布年份 2015

来源: Springer

【 摘 要 】

BackgroundDepressive symptoms and decreased physical functioning are interrelated conditions and common in older persons, causing significant individual and societal burden. Evidence suggests that vitamin D supplementation may be beneficial for both mental and physical functioning. However, previous randomized controlled trials have yielded inconsistent results and often had suboptimal designs. This study examines the effect of vitamin D supplementation on both depressive symptoms and physical functioning in a high-risk population of older persons with low vitamin D status.Methods/designThe D-Vitaal study is a randomized, double-blind, placebo-controlled trial investigating the effects of a daily dose of 1200 IU vitamin D3 versus placebo for one year on depressive symptoms and physical functioning (primary outcomes) in older adults. Participants (N = 155, age 60–80 years) were recruited from the general population. Eligibility criteria included the presence of depressive symptoms, ≥1 functional limitation and serum 25-hydroxyvitamin D levels between 15 and 50/70 nmol/L (depending on season). Secondary outcomes include incidence of major depressive disorder, anxiety symptoms, health-related quality of life, cognitive function and cost-effectiveness of the intervention.DiscussionWith this study, we aim to elucidate the effects of vitamin D supplementation on depressive symptoms and physical functioning in older persons who are at high risk of developing more substantial mental and physical problems. If effective, vitamin D supplementation can be a preventive intervention strategy that is easy to implement in the primary care setting.Trial registrationNetherlands Trial Register NTR3845. Registered 6 February 2013.

【 授权许可】

CC BY   
© de Koning et al. 2015