Nutrients, Vol. 18, Pages 357: Effect of Vitamin D Supplementation on Cardiometabolic Outcomes in Older Australian Adults—Results from the Randomized Controlled D-Health Trial
Nutrients doi: 10.3390/nu18020357
Authors:
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
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.
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. Read More