The Vitamin DAssessment (ViDA) Study: design of a randomized controlled trial of vitamin D supplementation for the prevention of cardiovascular disease, acute respiratory infection, falls and non-vertebral fractures.
J Steroid Biochem Mol Biol. 2015 Sep 10. pii: S0960-0760(15)30070-4. doi: 10.1016/j.jsbmb.2015.09.010.
Scragg R1, Waayer D2, Stewart AW2, Lawes CM2, Toop L3, Murphy J2, Khaw KT4, Camargo CA Jr5.
1School of Population Health, The University of Auckland, Auckland, New Zealand. Electronic address: r.scragg at auckland.ac.nz.
2School of Population Health, The University of Auckland, Auckland, New Zealand.
3Department of Public Health & General Practice, The University of Otago, Christchurch, New Zealand.
4Department of Public Health, University of Cambridge, Cambridge, United Kingdom.
5Department of Emergency Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, USA.
Observational studies have shown that low vitamin D status is associated with an increased risk of cardiovascular disease, acute respiratory infection, falls and non-vertebral fractures. We recruited 5110 Auckland adults, aged 50-84 years, into a randomized, double-blind, placebo-controlled trial to test whether vitamin D supplementation protects against these four major outcomes. The intervention is a monthly cholecalciferol dose of 100,000 IU (2.5mg) for an estimated median 3.3 years (range 2.5-4.2) during 2011-2015. Participants were recruited primarily from family practices, plus community groups with a high proportion of Maori, Pacific, or South Asian individuals. The baseline evaluation included medical history, lifestyle, physical measurements (e.g. blood pressure, arterial waveform, lung function, muscle function), and a blood sample (stored at -80®C for later testing). Capsules are being mailed to home addresses with a questionnaire to collect data on non-hospitalized outcomes and to monitor adherence and potential adverse effects. Other data sources include New Zealand Ministry of Health data on mortality, hospitalization, cancer registrations and dispensed pharmaceuticals. A random sample of 438 participants returned for annual collection of blood samples to monitor adherence and safety (hypercalcemia), including repeat physical measurements at 12 months follow-up. The trial will allow testing of a priori hypotheses on several other endpoints including: weight, blood pressure, arterial waveform parameters, heart rate variability, lung function, muscle strength, gait and balance, mood, psoriasis, bone density, and chronic pain.
Copyright © 2015. Published by Elsevier Ltd.
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- cardiovascular disease, hypertension, type 2 diabetes, infection (eg. TB, pneumonia), autoimmune disease (eg. type 1 diabetes, multiple sclerosis) and cancer (particularly colorectal)