Recruitment and Results of a Pilot Trial of Vitamin D Supplementation in the General Population of Australia
The Journal of Clinical Endocrinology & Metabolism October 12, 2012 jc.2012-2682
Bich Tran, Bruce K. Armstrong, John B. Carlin, Peter R. Ebeling, Dallas R. English, Michael G. Kimlin, Bayzidur Rahman, Jolieke C. van der Pols, Alison Venn, Val Gebski, David C. Whiteman, Penelope M. Webb and Rachel E. Neale
Population Health Division! (B.T., J.C.v.d.P., D.C.W., P.M.W., R.E.N.), Queensland Institute of Medical Research, Brisbane, Queensland 4006, Australia; Sydney School of Public Health (B.K.A.) and National Health and Medical Research Council Clinical Trials Centre (V.G.), Sydney Medical School, University of Sydney, Sydney, New South Wales 2006, Australia; School of Population Health (J.B.C., D.R.E.), University of Melbourne, and University of Melbourne and Western Health (P.R.E.), Parkville, Victoria 3010, Australia; Centre for Research Excellence in Sun and Health (B.T., M.G.K., D.C.W., R.E.N.) and AusSun Research Laboratory (M.G.K.), Queensland University of Technology, Brisbane, Queensland 4001, Australia; The School of Public Health and Community Medicine (B.R.), The University of New South Wales, Kensington, New South Wales 2052, Australia; and Menzies Research Institute Tasmania (A.V.), Hobart, Tasmania 7000, Australia
Address all correspondence and requests for reprints to: Rachel Neale, Ph.D., Queensland Institute of Medical Research, 300 Herston Road, Herston, Brisbane, Queensland 4006, Australia. E-mail: rachel.neale at qimr.edu.au.
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.
Received July 4, 2012.
Accepted September 17, 2012.
Max amount was 60,000 IU monthly = 2,000 IU daily (also tried 1,000 IU)
Vitamin D levels for seniors 17 ng ==> 31 ng with 2,000 IU daily average
Note: 90% of the Australians did participate - perhaps because they did not want ti have low, very low, or no vitamin D for an entire year
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