A pilot trial of vitamin D for the reduction of chronic disease and mortality in older adults.
- Conditions
- This trial is using healthy volunteers from the electoral roll. The overall aim of this study is 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.Public Health - Other public health
- Registration Number
- ACTRN12609001063202
- Lead Sponsor
- Queensland Institute of Medical Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 660
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Feasibility: compliance (self report)[At the end of the intervention participants will be asked to report the number of tablets taken.];Feasibility: compliance (serum Vitamin D levels)[Blood tests will be taken at baseline and at 12 months (cessation of the intervention).];Feasibility: recruitment rate and representativeness[Using baseline questionnaires to assess variation in participation across population subgroups.]
- Secondary Outcome Measures
Name Time Method il[Nil]