Recruitment and Results of a Pilot Trial of Vitamin D Supplementation in the General Population of Australia
The Journal of Clinical Endocrinology & Metabolism December 1, 2012 vol. 97 no. 12 4473-4480 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: firstname.lastname@example.org.
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.
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That at least 2,000 IU of vitamin D is needed by healthy, white, low weight, young people around the world has been proven again and again.
This is yet another example.
Expect that they were just trying to get to 20 ng level of vitamin D
Wonder if they realized how much more is needed to get to 30, 40 or even 50 ng of vitamin D
By the way: more vitamin D supplementation is needed by people who do not fit into those categories,
that is, those who are typically at risk of being very vitamin D deficient:
- Dark skin
- Pregnant, etc.
- 30 percent of bottles recommended more than 2000 IU of vitamin D – Dec 2012
- Overview How Much vitamin D
- Vitamin D Recommendations around the world - IU and ng
- Vitamin D researchers are taking 2000 to 10000 IU – July 2010
- 1500 IU vitamin D minimum - 10,000 IU is safe – review April 2012
- 3 % of elderly took more than 2000 IU in 2008
- Back in 2008 Scientists called for 2,000 IU
- 10,000 Finnish children got 2000 IU chart
- 1950's-1964 Finnish children got 4000+ IU chart
- 1800 to 4000 IU vitamin D to get 30 to-44 ng no risk osteo - July 2010.pdf file
- Linus Pauling Institute 2000 IU Dec 2011
- Nursing homes residents should have at least 2000 IU
- Patients older than 65 needed 5,000 IU vitamin D – May 2010
- 2500 to 4000 IU would decrease specific disease rates - April 2010
- Elderly need 2000 to 3000 IU
- Dr Norman 2000 to 4000 IU
- 85% achieved 20 ng with avg of 3300 IU of vitamin D - oral and injection Aug 2012
- Dr. Garland and Heaney 4000 IU
- 7100 IU (50000 weekly) got most women to 30 ng of vitamin D - Aug 2012
- How often should I take 50000 IU (1.25 mg) of vitamin D
several times a week, several times a month, monthly . . .
- Overview Vitamin D Dose-Response
- All items in category How Much Vitamin D
- New Zealand doctors are starting to prescribe more sunshine – Aug 2012
- 10X increase in vitamin D tests in Australia – time for the doctors to learn about vitamin D – April 2011
- All items in category Australia and NZ
- 73 % of Australians had too little vitamin D a decade ago – Dec 2011
- Australia and NZ conservative position vitamin D position statement – June 2012
- Should NZ and Australia increase vitamin D fortification - June 2012
- Majority of those living in the ozone hole lack vitamin D Blog post March 15 2012
- New Zealand consensus: at risk should take more Vitamin D – March 2012
- Black Sudanese children 350X more likely to have rickets than white Australians – April 2012