Effect of vitamin D supplementation on cardiometabolic outcomes in older Australian adults—results from the randomized controlled D-health trial

Briony L. Duarte Romero; Bruce K. Armstrong; Catherine Baxter; Dallas R. English; Peter R. Ebeling; Gunter Hartel; Michael G. Kimlin; Renhua Na; Donald S.A. McLeod; Hai Pham; Tanya Ross; Jolieke C. van der Pols; Alison J. Venn; Penelope M. Webb; David C. Whiteman; Rachel E. Neale; Mary Waterhouse

doi:10.3390/nu18020357

Effect of vitamin D supplementation on cardiometabolic outcomes in older Australian adults—results from the randomized controlled D-health trial

Briony L. Duarte Romero
, Bruce K. Armstrong
, Catherine Baxter
, Dallas R. English
, Peter R. Ebeling
, Gunter Hartel
, Michael G. Kimlin
, Renhua Na
, Donald S.A. McLeod
, Hai Pham
, Tanya Ross
, Jolieke C. van der Pols
, Alison J. Venn
, Penelope M. Webb
, David C. Whiteman
, Rachel E. Neale^*
, Mary Waterhouse

^*Corresponding author for this work

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

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Abstract

Background/Objectives:

Observational studies have found inverse associations between 25-hydroxyvitamin D concentration and risk of hypertension, hypercholesterolemia and type 2 diabetes (T2D). More robust evidence from large-scale randomized controlled trials, however, is limited or inconclusive.

Methods:

The D-Health Trial (N = 21,315) is a randomized, double-blind, placebo-controlled trial of supplementation with monthly doses of 60,000 international units of oral vitamin D₃, conducted in Australians aged 60–84 years. Commencing treatment with anti-hypertensive, lipid-modifying, or anti-diabetic drugs was used as a surrogate for incident hypertension, hypercholesterolemia, and T2D, respectively. Outcomes were ascertained via linkage with the Australian Pharmaceutical Benefits Scheme database. Follow-up began 6 months after randomization; we excluded participants without linked data, and those who were prevalent cases or who died prior to start of follow-up. Flexible parametric survival models were used to estimate the effect of vitamin D supplementation on each outcome.

Results:

We included 10,964 participants (vitamin D, n = 5456 [49.8%]; placebo, n = 5508 [50.2%]) in the analysis of hypertension, 12,126 participants (vitamin D, n = 6038 [49.8%]; placebo, n = 6088 [50.2%]) in the analysis of hypercholesterolemia, and 17,846 (vitamin D, n = 8931 [50.0%]; placebo, n = 8915 [50.0%]) in the analysis of T2D. Over a median follow-up of 4.6 years, 2672 (24.4%), 2554 (21.1%), and 779 (4.4%) participants developed hypertension, hypercholesterolemia, and T2D, respectively. Vitamin D supplementation had no material effect on the incidence of any of hypertension (HR 1.00; 95% CI 0.93 to 1.08), hypercholesterolemia (HR 1.05; 95% CI 0.97 to 1.13), or T2D (HR 0.97; 95% CI 0.84 to 1.12).

Conclusions:

Monthly supplements of vitamin D did not alter the incidence of any of the three conditions in older, largely vitamin D-replete Australians.

Original language	English
Article number	357
Pages (from-to)	1-14
Number of pages	14
Journal	Nutrients
Volume	18
Issue number	2
DOIs	https://doi.org/10.3390/nu18020357
Publication status	Published - 22 Jan 2026

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SDG 3 Good Health and Well-being

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Effect of vitamin D supplementation on cardiometabolic outcomes in older Australian adults—results from the randomized controlled D-health trialFinal published version, 910 KBLicence: CC BY

Cite this

Duarte Romero, B. L., Armstrong, B. K., Baxter, C., English, D. R., Ebeling, P. R., Hartel, G., Kimlin, M. G., Na, R., McLeod, D. S. A., Pham, H., Ross, T., van der Pols, J. C., Venn, A. J., Webb, P. M., Whiteman, D. C., Neale, R. E., & Waterhouse, M. (2026). Effect of vitamin D supplementation on cardiometabolic outcomes in older Australian adults—results from the randomized controlled D-health trial. Nutrients, 18(2), 1-14. Article 357. https://doi.org/10.3390/nu18020357

@article{f1e81b26966d4dcd8c4d8f2e4e27adc2,

title = "Effect of vitamin D supplementation on cardiometabolic outcomes in older Australian adults—results from the randomized controlled D-health trial",

abstract = "Background/Objectives: Observational studies have found inverse associations between 25-hydroxyvitamin D concentration and risk of hypertension, hypercholesterolemia and type 2 diabetes (T2D). More robust evidence from large-scale randomized controlled trials, however, is limited or inconclusive. Methods: The D-Health Trial (N = 21,315) is a randomized, double-blind, placebo-controlled trial of supplementation with monthly doses of 60,000 international units of oral vitamin D3, conducted in Australians aged 60–84 years. Commencing treatment with anti-hypertensive, lipid-modifying, or anti-diabetic drugs was used as a surrogate for incident hypertension, hypercholesterolemia, and T2D, respectively. Outcomes were ascertained via linkage with the Australian Pharmaceutical Benefits Scheme database. Follow-up began 6 months after randomization; we excluded participants without linked data, and those who were prevalent cases or who died prior to start of follow-up. Flexible parametric survival models were used to estimate the effect of vitamin D supplementation on each outcome.Results: We included 10,964 participants (vitamin D, n = 5456 [49.8\%]; placebo, n = 5508 [50.2\%]) in the analysis of hypertension, 12,126 participants (vitamin D, n = 6038 [49.8\%]; placebo, n = 6088 [50.2\%]) in the analysis of hypercholesterolemia, and 17,846 (vitamin D, n = 8931 [50.0\%]; placebo, n = 8915 [50.0\%]) in the analysis of T2D. Over a median follow-up of 4.6 years, 2672 (24.4\%), 2554 (21.1\%), and 779 (4.4\%) participants developed hypertension, hypercholesterolemia, and T2D, respectively. Vitamin D supplementation had no material effect on the incidence of any of hypertension (HR 1.00; 95\% CI 0.93 to 1.08), hypercholesterolemia (HR 1.05; 95\% CI 0.97 to 1.13), or T2D (HR 0.97; 95\% CI 0.84 to 1.12). Conclusions: Monthly supplements of vitamin D did not alter the incidence of any of the three conditions in older, largely vitamin D-replete Australians.",

author = "\{Duarte Romero\}, \{Briony L.\} and Armstrong, \{Bruce K.\} and Catherine Baxter and English, \{Dallas R.\} and Ebeling, \{Peter R.\} and Gunter Hartel and Kimlin, \{Michael G.\} and Renhua Na and McLeod, \{Donald S.A.\} and Hai Pham and Tanya Ross and \{van der Pols\}, \{Jolieke C.\} and Venn, \{Alison J.\} and Webb, \{Penelope M.\} and Whiteman, \{David C.\} and Neale, \{Rachel E.\} and Mary Waterhouse",

note = "Publisher Copyright: {\textcopyright} 2026 by the authors.",

year = "2026",

month = jan,

day = "22",

doi = "10.3390/nu18020357",

language = "English",

volume = "18",

pages = "1--14",

journal = "Nutrients",

issn = "2072-6643",

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number = "2",

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Duarte Romero, BL, Armstrong, BK, Baxter, C, English, DR, Ebeling, PR, Hartel, G, Kimlin, MG, Na, R, McLeod, DSA, Pham, H, Ross, T, van der Pols, JC, Venn, AJ, Webb, PM, Whiteman, DC, Neale, RE & Waterhouse, M 2026, 'Effect of vitamin D supplementation on cardiometabolic outcomes in older Australian adults—results from the randomized controlled D-health trial', Nutrients, vol. 18, no. 2, 357, pp. 1-14. https://doi.org/10.3390/nu18020357

TY - JOUR

T1 - Effect of vitamin D supplementation on cardiometabolic outcomes in older Australian adults—results from the randomized controlled D-health trial

AU - Duarte Romero, Briony L.

AU - Armstrong, Bruce K.

AU - Baxter, Catherine

AU - English, Dallas R.

AU - Ebeling, Peter R.

AU - Hartel, Gunter

AU - Kimlin, Michael G.

AU - Na, Renhua

AU - McLeod, Donald S.A.

AU - Pham, Hai

AU - Ross, Tanya

AU - van der Pols, Jolieke C.

AU - Venn, Alison J.

AU - Webb, Penelope M.

AU - Whiteman, David C.

AU - Neale, Rachel E.

AU - Waterhouse, Mary

PY - 2026/1/22

Y1 - 2026/1/22

N2 - Background/Objectives: Observational studies have found inverse associations between 25-hydroxyvitamin D concentration and risk of hypertension, hypercholesterolemia and type 2 diabetes (T2D). More robust evidence from large-scale randomized controlled trials, however, is limited or inconclusive. Methods: The D-Health Trial (N = 21,315) is a randomized, double-blind, placebo-controlled trial of supplementation with monthly doses of 60,000 international units of oral vitamin D3, conducted in Australians aged 60–84 years. Commencing treatment with anti-hypertensive, lipid-modifying, or anti-diabetic drugs was used as a surrogate for incident hypertension, hypercholesterolemia, and T2D, respectively. Outcomes were ascertained via linkage with the Australian Pharmaceutical Benefits Scheme database. Follow-up began 6 months after randomization; we excluded participants without linked data, and those who were prevalent cases or who died prior to start of follow-up. Flexible parametric survival models were used to estimate the effect of vitamin D supplementation on each outcome.Results: We included 10,964 participants (vitamin D, n = 5456 [49.8%]; placebo, n = 5508 [50.2%]) in the analysis of hypertension, 12,126 participants (vitamin D, n = 6038 [49.8%]; placebo, n = 6088 [50.2%]) in the analysis of hypercholesterolemia, and 17,846 (vitamin D, n = 8931 [50.0%]; placebo, n = 8915 [50.0%]) in the analysis of T2D. Over a median follow-up of 4.6 years, 2672 (24.4%), 2554 (21.1%), and 779 (4.4%) participants developed hypertension, hypercholesterolemia, and T2D, respectively. Vitamin D supplementation had no material effect on the incidence of any of hypertension (HR 1.00; 95% CI 0.93 to 1.08), hypercholesterolemia (HR 1.05; 95% CI 0.97 to 1.13), or T2D (HR 0.97; 95% CI 0.84 to 1.12). Conclusions: Monthly supplements of vitamin D did not alter the incidence of any of the three conditions in older, largely vitamin D-replete Australians.

AB - Background/Objectives: Observational studies have found inverse associations between 25-hydroxyvitamin D concentration and risk of hypertension, hypercholesterolemia and type 2 diabetes (T2D). More robust evidence from large-scale randomized controlled trials, however, is limited or inconclusive. Methods: The D-Health Trial (N = 21,315) is a randomized, double-blind, placebo-controlled trial of supplementation with monthly doses of 60,000 international units of oral vitamin D3, conducted in Australians aged 60–84 years. Commencing treatment with anti-hypertensive, lipid-modifying, or anti-diabetic drugs was used as a surrogate for incident hypertension, hypercholesterolemia, and T2D, respectively. Outcomes were ascertained via linkage with the Australian Pharmaceutical Benefits Scheme database. Follow-up began 6 months after randomization; we excluded participants without linked data, and those who were prevalent cases or who died prior to start of follow-up. Flexible parametric survival models were used to estimate the effect of vitamin D supplementation on each outcome.Results: We included 10,964 participants (vitamin D, n = 5456 [49.8%]; placebo, n = 5508 [50.2%]) in the analysis of hypertension, 12,126 participants (vitamin D, n = 6038 [49.8%]; placebo, n = 6088 [50.2%]) in the analysis of hypercholesterolemia, and 17,846 (vitamin D, n = 8931 [50.0%]; placebo, n = 8915 [50.0%]) in the analysis of T2D. Over a median follow-up of 4.6 years, 2672 (24.4%), 2554 (21.1%), and 779 (4.4%) participants developed hypertension, hypercholesterolemia, and T2D, respectively. Vitamin D supplementation had no material effect on the incidence of any of hypertension (HR 1.00; 95% CI 0.93 to 1.08), hypercholesterolemia (HR 1.05; 95% CI 0.97 to 1.13), or T2D (HR 0.97; 95% CI 0.84 to 1.12). Conclusions: Monthly supplements of vitamin D did not alter the incidence of any of the three conditions in older, largely vitamin D-replete Australians.

UR - https://www.scopus.com/pages/publications/105028819537

U2 - 10.3390/nu18020357

DO - 10.3390/nu18020357

M3 - Article

C2 - 41599971

AN - SCOPUS:105028819537

SN - 2072-6643

VL - 18

SP - 1

EP - 14

JO - Nutrients

JF - Nutrients

IS - 2

M1 - 357

ER -

Effect of vitamin D supplementation on cardiometabolic outcomes in older Australian adults—results from the randomized controlled D-health trial

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