Recruitment and results of a pilot trial of vitamin D supplementation in the general population of Australia

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; Rachel E. Neale

doi:10.1210/jc.2012-2682

Recruitment and results of a pilot trial of vitamin D supplementation in the general population of Australia

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, Rachel E. Neale^*

^*Corresponding author for this work

Research output: Contribution to journal › Article › Research › peer-review

21 Citations (Scopus)

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.

Original language	English
Pages (from-to)	4473-4480
Number of pages	8
Journal	Journal of Clinical Endocrinology and Metabolism
Volume	97
Issue number	12
DOIs	https://doi.org/10.1210/jc.2012-2682
Publication status	Published - Dec 2012
Externally published	Yes

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.1210/jc.2012-2682Licence: Free to read

Cite this

Tran, B., Armstrong, B. K., Carlin, J. B., Ebeling, P. R., English, D. R., Kimlin, M. G., Rahman, B., Van Der Pols, J. C., Venn, A., Gebski, V., Whiteman, D. C., Webb, P. M., & Neale, R. E. (2012). Recruitment and results of a pilot trial of vitamin D supplementation in the general population of Australia. Journal of Clinical Endocrinology and Metabolism, 97(12), 4473-4480. https://doi.org/10.1210/jc.2012-2682

@article{da8dfd627963473c97071454b553bf0c,

title = "Recruitment and results of a pilot trial of vitamin D supplementation in the general population of Australia",

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.",

author = "Bich Tran and Armstrong, {Bruce K.} and Carlin, {John B.} and Ebeling, {Peter R.} and English, {Dallas R.} and Kimlin, {Michael G.} and Bayzidur Rahman and {Van Der Pols}, {Jolieke C.} and Alison Venn and Val Gebski and Whiteman, {David C.} and Webb, {Penelope M.} and Neale, {Rachel E.}",

year = "2012",

month = dec,

doi = "10.1210/jc.2012-2682",

language = "English",

volume = "97",

pages = "4473--4480",

journal = "Journal of Clinical Endocrinology and Metabolism",

issn = "0021-972X",

publisher = "The Endocrine Society",

number = "12",

}

Tran, B, Armstrong, BK, Carlin, JB, Ebeling, PR, English, DR, Kimlin, MG, Rahman, B, Van Der Pols, JC, Venn, A, Gebski, V, Whiteman, DC, Webb, PM & Neale, RE 2012, '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, no. 12, pp. 4473-4480. https://doi.org/10.1210/jc.2012-2682

TY - JOUR

T1 - Recruitment and results of a pilot trial of vitamin D supplementation in the general population of Australia

AU - Tran, Bich

AU - Armstrong, Bruce K.

AU - Carlin, John B.

AU - Ebeling, Peter R.

AU - English, Dallas R.

AU - Kimlin, Michael G.

AU - Rahman, Bayzidur

AU - Van Der Pols, Jolieke C.

AU - Venn, Alison

AU - Gebski, Val

AU - Whiteman, David C.

AU - Webb, Penelope M.

AU - Neale, Rachel E.

PY - 2012/12

Y1 - 2012/12

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=84870746406&partnerID=8YFLogxK

U2 - 10.1210/jc.2012-2682

DO - 10.1210/jc.2012-2682

M3 - Article

C2 - 23066119

AN - SCOPUS:84870746406

SN - 0021-972X

VL - 97

SP - 4473

EP - 4480

JO - Journal of Clinical Endocrinology and Metabolism

JF - Journal of Clinical Endocrinology and Metabolism

IS - 12

ER -

Recruitment and results of a pilot trial of vitamin D supplementation in the general population of Australia

Abstract

UN SDGs

Access to Document

Other files and links

Fingerprint

Cite this