Vitamin D3 supplementation has no effect on conventional cardiovascular risk factors: a parallel-group, double-blind, placebo-controlled RCT

Adrian D. Wood, Karen R. Secombes, Frank Thies, Lorna Aucott, Alison J. Black, Alexandra Mavroeidi, William G. Simpson, William D. Fraser, David M. Reid, Helen M. Macdonald (Corresponding Author)

Research output: Contribution to journalArticle

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Abstract

Context: Observational studies show an association between low vitamin D status assessed by circulating 25-hydroxyvitamin D and cardiovascular events and mortality. Data from randomized controlled trials are limited.

Objective: The aim of this study was to test whether daily doses of vitamin D3 at 400 or 1000 IU/d for 1 yr affected conventional markers of cardiovascular disease (CVD) risk.

Design: We conducted a parallel-group, double-blind, placebo-controlled randomized controlled trial. Randomization was computer generated. Participants and study investigators were blinded to intervention groupings throughout the trial.

Setting: The study was conducted at the Clinical Research Facility, University of Aberdeen, United Kingdom.

Participants: A total of 305 healthy postmenopausal women aged 60–70 yr were recruited for the study.

Intervention: Each woman received a daily capsule of 400 or 1000 IU vitamin D3 or placebo randomly allocated.

Main Outcome Measures: Primary outcomes were serum lipid profile [total, high-density lipoprotein, and low-density lipoprotein cholesterol; triglycerides; and apolipoproteins A-1 and B100], insulin resistance (homeostatic model assessment), inflammatory biomarkers (high-sensitivity C-reactive protein, IL-6, soluble intracellular adhesion molecule-1), and blood pressure.

Results: A total of 265 (87%) participants completed all study visits. Small differences between groups for serum apolipoprotein B100 change [repeated measures ANOVA, P = 0.04; mean (sd), -1.0 (10.0) mg/dl (400 IU); -1.0 (10.0) mg/dl (1000 IU); and +0.02 (10.0) mg/dl (placebo)] were not considered clinically significant. Other systemic markers for CVD risk remained unchanged. There was significant seasonal variation in systolic and diastolic blood pressure independent of vitamin D dose (P < 0.001, linear mixed model). Mean (sd) reduction in systolic blood pressure from winter to summer was -6.6 (10.8) mm Hg.

Conclusions: Improving vitamin D status through dietary supplementation is unlikely to reduce CVD risk factors. Confounding of seasonality should be recognized and addressed in future studies of vitamin D.
Original languageEnglish
Pages (from-to)3557-3568
Number of pages12
JournalJournal of Clinical Endocrinology and Metabolism
Volume97
Issue number10
Early online date3 Aug 2012
DOIs
Publication statusPublished - 1 Oct 2012

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Cholecalciferol
Vitamin D
Blood pressure
Placebos
Blood Pressure
Cardiovascular Diseases
Randomized Controlled Trials
Apolipoproteins
Apolipoprotein A-I
Biomarkers
HDL Lipoproteins
Analysis of variance (ANOVA)
C-Reactive Protein
LDL Cholesterol
Capsules
Interleukin-6
Random Allocation
Dietary Supplements
Triglycerides
Serum

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Vitamin D3 supplementation has no effect on conventional cardiovascular risk factors : a parallel-group, double-blind, placebo-controlled RCT. / Wood, Adrian D.; Secombes, Karen R.; Thies, Frank; Aucott, Lorna; Black, Alison J.; Mavroeidi, Alexandra; Simpson, William G.; Fraser, William D.; Reid, David M.; Macdonald, Helen M. (Corresponding Author).

In: Journal of Clinical Endocrinology and Metabolism, Vol. 97, No. 10, 01.10.2012, p. 3557-3568.

Research output: Contribution to journalArticle

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abstract = "Context: Observational studies show an association between low vitamin D status assessed by circulating 25-hydroxyvitamin D and cardiovascular events and mortality. Data from randomized controlled trials are limited. Objective: The aim of this study was to test whether daily doses of vitamin D3 at 400 or 1000 IU/d for 1 yr affected conventional markers of cardiovascular disease (CVD) risk. Design: We conducted a parallel-group, double-blind, placebo-controlled randomized controlled trial. Randomization was computer generated. Participants and study investigators were blinded to intervention groupings throughout the trial. Setting: The study was conducted at the Clinical Research Facility, University of Aberdeen, United Kingdom. Participants: A total of 305 healthy postmenopausal women aged 60–70 yr were recruited for the study. Intervention: Each woman received a daily capsule of 400 or 1000 IU vitamin D3 or placebo randomly allocated. Main Outcome Measures: Primary outcomes were serum lipid profile [total, high-density lipoprotein, and low-density lipoprotein cholesterol; triglycerides; and apolipoproteins A-1 and B100], insulin resistance (homeostatic model assessment), inflammatory biomarkers (high-sensitivity C-reactive protein, IL-6, soluble intracellular adhesion molecule-1), and blood pressure. Results: A total of 265 (87{\%}) participants completed all study visits. Small differences between groups for serum apolipoprotein B100 change [repeated measures ANOVA, P = 0.04; mean (sd), -1.0 (10.0) mg/dl (400 IU); -1.0 (10.0) mg/dl (1000 IU); and +0.02 (10.0) mg/dl (placebo)] were not considered clinically significant. Other systemic markers for CVD risk remained unchanged. There was significant seasonal variation in systolic and diastolic blood pressure independent of vitamin D dose (P < 0.001, linear mixed model). Mean (sd) reduction in systolic blood pressure from winter to summer was -6.6 (10.8) mm Hg. Conclusions: Improving vitamin D status through dietary supplementation is unlikely to reduce CVD risk factors. Confounding of seasonality should be recognized and addressed in future studies of vitamin D.",
author = "Wood, {Adrian D.} and Secombes, {Karen R.} and Frank Thies and Lorna Aucott and Black, {Alison J.} and Alexandra Mavroeidi and Simpson, {William G.} and Fraser, {William D.} and Reid, {David M.} and Macdonald, {Helen M.}",
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T2 - a parallel-group, double-blind, placebo-controlled RCT

AU - Wood, Adrian D.

AU - Secombes, Karen R.

AU - Thies, Frank

AU - Aucott, Lorna

AU - Black, Alison J.

AU - Mavroeidi, Alexandra

AU - Simpson, William G.

AU - Fraser, William D.

AU - Reid, David M.

AU - Macdonald, Helen M.

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N2 - Context: Observational studies show an association between low vitamin D status assessed by circulating 25-hydroxyvitamin D and cardiovascular events and mortality. Data from randomized controlled trials are limited. Objective: The aim of this study was to test whether daily doses of vitamin D3 at 400 or 1000 IU/d for 1 yr affected conventional markers of cardiovascular disease (CVD) risk. Design: We conducted a parallel-group, double-blind, placebo-controlled randomized controlled trial. Randomization was computer generated. Participants and study investigators were blinded to intervention groupings throughout the trial. Setting: The study was conducted at the Clinical Research Facility, University of Aberdeen, United Kingdom. Participants: A total of 305 healthy postmenopausal women aged 60–70 yr were recruited for the study. Intervention: Each woman received a daily capsule of 400 or 1000 IU vitamin D3 or placebo randomly allocated. Main Outcome Measures: Primary outcomes were serum lipid profile [total, high-density lipoprotein, and low-density lipoprotein cholesterol; triglycerides; and apolipoproteins A-1 and B100], insulin resistance (homeostatic model assessment), inflammatory biomarkers (high-sensitivity C-reactive protein, IL-6, soluble intracellular adhesion molecule-1), and blood pressure. Results: A total of 265 (87%) participants completed all study visits. Small differences between groups for serum apolipoprotein B100 change [repeated measures ANOVA, P = 0.04; mean (sd), -1.0 (10.0) mg/dl (400 IU); -1.0 (10.0) mg/dl (1000 IU); and +0.02 (10.0) mg/dl (placebo)] were not considered clinically significant. Other systemic markers for CVD risk remained unchanged. There was significant seasonal variation in systolic and diastolic blood pressure independent of vitamin D dose (P < 0.001, linear mixed model). Mean (sd) reduction in systolic blood pressure from winter to summer was -6.6 (10.8) mm Hg. Conclusions: Improving vitamin D status through dietary supplementation is unlikely to reduce CVD risk factors. Confounding of seasonality should be recognized and addressed in future studies of vitamin D.

AB - Context: Observational studies show an association between low vitamin D status assessed by circulating 25-hydroxyvitamin D and cardiovascular events and mortality. Data from randomized controlled trials are limited. Objective: The aim of this study was to test whether daily doses of vitamin D3 at 400 or 1000 IU/d for 1 yr affected conventional markers of cardiovascular disease (CVD) risk. Design: We conducted a parallel-group, double-blind, placebo-controlled randomized controlled trial. Randomization was computer generated. Participants and study investigators were blinded to intervention groupings throughout the trial. Setting: The study was conducted at the Clinical Research Facility, University of Aberdeen, United Kingdom. Participants: A total of 305 healthy postmenopausal women aged 60–70 yr were recruited for the study. Intervention: Each woman received a daily capsule of 400 or 1000 IU vitamin D3 or placebo randomly allocated. Main Outcome Measures: Primary outcomes were serum lipid profile [total, high-density lipoprotein, and low-density lipoprotein cholesterol; triglycerides; and apolipoproteins A-1 and B100], insulin resistance (homeostatic model assessment), inflammatory biomarkers (high-sensitivity C-reactive protein, IL-6, soluble intracellular adhesion molecule-1), and blood pressure. Results: A total of 265 (87%) participants completed all study visits. Small differences between groups for serum apolipoprotein B100 change [repeated measures ANOVA, P = 0.04; mean (sd), -1.0 (10.0) mg/dl (400 IU); -1.0 (10.0) mg/dl (1000 IU); and +0.02 (10.0) mg/dl (placebo)] were not considered clinically significant. Other systemic markers for CVD risk remained unchanged. There was significant seasonal variation in systolic and diastolic blood pressure independent of vitamin D dose (P < 0.001, linear mixed model). Mean (sd) reduction in systolic blood pressure from winter to summer was -6.6 (10.8) mm Hg. Conclusions: Improving vitamin D status through dietary supplementation is unlikely to reduce CVD risk factors. Confounding of seasonality should be recognized and addressed in future studies of vitamin D.

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DO - 10.1210/jc.2012-2126

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JO - Journal of Clinical Endocrinology and Metabolism

JF - Journal of Clinical Endocrinology and Metabolism

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