Journal article
Recruitment and results of a pilot trial of vitamin D supplementation in the general population of Australia
Journal of Clinical Endocrinology and Metabolism, Vol.97(12), pp.4473-4480
2012
Abstract
Context: The benefits of high serum levels of 25-hydroxyvitamin D [25(OH)D] are unclear. Trials are needed to establish an appropriate evidence base. Objective: We plan to conduct a large-scale trial of vitamin D supplementation for the reduction of cancer incidence and overall mortality and report here the methods and results of a pilot trial established to inform its design. Design: Pilot D-Health was a randomized trial carried out in a general community setting with 12 months intervention and follow-up. Participants: Participants were 60- to 84-yr-old residents of one of the four eastern Australian states who did not have any vitamin D-related disorders and who were not taking more than 400 IU supplementary vitamin D per day. A total of 644 participants were randomized, and 615 completed the study (two persons withdrew because of nonserious adverse events). Interventions: The interventions were monthly doses of placebo or 30,000 or 60,000 IU vitamin D3. Main Outcomes: The main outcomes were the recruitment rate and changes in serum 25(OH)D. Results: Ten percent of those approached were recruited. At baseline, the mean 25(OH)D was 42 nmol/liter in all three study arms. The mean change in 25(OH)D in the placebo group was 0.12 nmol/liter, compared with changes of 22 and 36 nmol/liter in the 30,000- and 60,000-IU groups, respectively. Conclusions: The D-Health pilot has shown that a large trial is feasible in Australia and that a dose of 2000 IU/d will be needed to ensure that a large proportion of the population reaches the target serum 25(OH)D level. Copyright © 2012 by The Endocrine Society.
Details
- Title
- Recruitment and results of a pilot trial of vitamin D supplementation in the general population of Australia
- Authors
- B Tran (Author) - Queensland Institute of Public HealthB K Armstrong (Author) - Sydney School of Public HealthJ B Carlin (Author) - University of SydneyP R Ebeling (Author) - University of MelbourneD R English (Author) - University of MelbourneMichael G Kimlin (Author) - Queensland University of TechnologyB Rahman (Author) - University of New South WalesJ C Van Der Pols (Author) - Queensland Institute of Public HealthA Venn (Author) - Menzies Research Institute TasmaniaV Gebski (Author) - University of SydneyD C Whiteman (Author) - Queensland Institute of Public HealthP M Webb (Author) - Queensland Institute of Public HealthR E Neale (Author) - Queensland Institute of Public Health
- Publication details
- Journal of Clinical Endocrinology and Metabolism, Vol.97(12), pp.4473-4480
- Publisher
- Endocrine Society
- Date published
- 2012
- DOI
- 10.1210/jc.2012-2682
- ISSN
- 0021-972X
- Copyright note
- Copyright © 2012 by The Endocrine Society. Reproduced with permission of the copyright holder.
- Organisation Unit
- University of the Sunshine Coast, Queensland; School of Health and Sport Sciences - Legacy
- Language
- English
- Record Identifier
- 99449600902621
- Output Type
- Journal article
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- Domestic collaboration
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- Endocrinology & Metabolism
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