A randomised placebo-controlled double-blind trial with participants randomised to receive either placebo, 60,000 International Units per month (IU/month) of vitamin D3 or 30,000 IU/month of vitamin D3, each taken once a month for 12 months with an aim to determine the feasibility and inform the design of a large-scale randomised, placebo-controlled chemoprevention trial of vitamin D3 (cholecalciferol) for the reduction of total mortality.

Queensland Institute of Medical Research0 个研究点目标入组 660 人开始时间: 2009年12月10日最近更新: 2020年1月13日

适应症

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•Residents in Queensland, New South Wales, Tasmania and Victoria aged between 60 and 85 years will be selected at random from the Commonwealth Electoral Roll. Half will be selected from capital cities and half from regional centres, selecting from postcodes that are within 20 kilometres of a pathology collection clinic. Selection will be stratified by state, region, age (in five-year age bands) and sex to ensure an equal state, region, age- and sex-distribution.

•People will be excluded if they are unable to give consent or to communicate well enough in English to understand study materials or if they indicate in an initial screening questionnaire that they:
•1.Have any of the following medical conditions (which either preclude or require high dose vitamin D supplementation or prevent informed consent): hyperparathyroidism, sarcoidosis, nephrolithiasis, osteomalacia, osteoporosis, a history of renal calculi or colic
•2. Are taking vitamin D at doses >600IU/day
•3. Do not have a telephone (landline or mobile)

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