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 D(3). 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.
RCT Entities:
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 D(3). 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.
Authors: Karin Ma Swart; Paul Lips; Ingeborg A Brouwer; Rolf Jorde; Martijn W Heymans; Guri Grimnes; Martin R Grübler; Martin Gaksch; Andreas Tomaschitz; Stefan Pilz; Gudny Eiriksdottir; Vilmundur Gudnason; Louise Wamberg; Lars Rejnmark; Christopher T Sempos; Ramón A Durazo-Arvizu; Kirsten G Dowling; George Hull; Zuzana Škrabáková; Mairead Kiely; Kevin D Cashman; Natasja M van Schoor Journal: Am J Clin Nutr Date: 2018-06-01 Impact factor: 7.045
Authors: Mica Hartley; Samuel Hoare; Fiona E Lithander; Rachel E Neale; Prue H Hart; Shelley Gorman; Peter Gies; Jill Sherriff; Ashwin Swaminathan; Lawrence J Beilin; Trevor A Mori; Laura King; Lucinda J Black; Kushani Marshall; Fan Xiang; Candy Wyatt; Kerryn King; Terry Slevin; Nirmala Pandeya; Robyn M Lucas Journal: BMC Public Health Date: 2015-02-10 Impact factor: 3.295
Authors: Visalini Nair-Shalliker; David P Smith; Val Gebski; Manish I Patel; Mark Frydenberg; John W Yaxley; Robert Gardiner; David Espinoza; Michael G Kimlin; Michael Fenech; David Gillatt; Henry Woo; Bruce K Armstrong; Krishan Rasiah; Nader Awad; James Symons; Howard Gurney Journal: BMJ Open Date: 2021-03-02 Impact factor: 2.692