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Recruitment and results of a pilot trial of vitamin D supplementation in the general population of Australia
Tran, B and Armstrong, BK and Carlin, JB and Ebeling, PR and English, DR and Kimlin, MG and Rahman, B and van der Pols, JC and Venn, A and Gebski, V and Whiteman, DC and Webb, PM and Neale, RE, Recruitment and results of a pilot trial of vitamin D supplementation in the general population of Australia, Journal of Clinical Endocrinology & Metabolism, 97, (12) pp. 4473-4480. ISSN 0021-972X (2012) [Refereed Article]
Copyright 2012 The Endocrine Society
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.
|Item Type:||Refereed Article|
|Research Division:||Health Sciences|
|Research Field:||Epidemiology not elsewhere classified|
|Objective Group:||Clinical health|
|Objective Field:||Clinical health not elsewhere classified|
|UTAS Author:||Venn, A (Professor Alison Venn)|
|Web of Science® Times Cited:||17|
|Deposited By:||Menzies Institute for Medical Research|
|Downloads:||361 View Download Statistics|
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