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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

Authors
  • de Koning, Elisa J.1, 2
  • van Schoor, Natasja M.1, 2
  • Penninx, Brenda W.J.H.1, 3
  • Elders, Petra J.M.1, 4
  • Heijboer, Annemieke C.5
  • Smit, Jan. H.1, 3
  • Bet, Pierre M.6
  • van Tulder, Maurits W.1, 7
  • den Heijer, Martin8
  • van Marwijk, Harm W.J.1, 4, 9
  • Lips, Paul1, 8
  • 1 EMGO Institute for Health and Care Research, VU University Medical Center, Amsterdam, 1007 MB, The Netherlands , Amsterdam (Netherlands)
  • 2 VU University Medical Center, Department of Epidemiology and Biostatistics, Amsterdam, 1007 MB, The Netherlands , Amsterdam (Netherlands)
  • 3 VU University Medical Center/GGZ inGeest, Department of Psychiatry, A.J. Ernststraat 1187, Amsterdam, The Netherlands , Amsterdam (Netherlands)
  • 4 VU University Medical Center, Department of General Practice and Elderly Care Medicine, Amsterdam, 1007 MB, The Netherlands , Amsterdam (Netherlands)
  • 5 VU University Medical Center, Department of Clinical Chemistry, Endocrine Laboratory, Amsterdam, 1007 MB, The Netherlands , Amsterdam (Netherlands)
  • 6 VU University Medical Center, Department of Clinical Pharmacology and Pharmacy, Amsterdam, 1007 MB, The Netherlands , Amsterdam (Netherlands)
  • 7 VU University, Department of Health Sciences, Amsterdam, 1007 MB, The Netherlands , Amsterdam (Netherlands)
  • 8 VU University Medical Center, Department of Internal Medicine, Endocrine section, Amsterdam, 1007 MB, The Netherlands , Amsterdam (Netherlands)
  • 9 Institute of Population Health, University of Manchester, Primary Care Research Centre, Oxford Road, Manchester, M13 9PL, United Kingdom , Manchester (United Kingdom)
Type
Published Article
Journal
BMC Geriatrics
Publisher
BioMed Central
Publication Date
Nov 19, 2015
Volume
15
Issue
1
Identifiers
DOI: 10.1186/s12877-015-0148-3
Source
Springer Nature
Keywords
License
Green

Abstract

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.

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