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

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128 Citations (Scopus)

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 D(3) 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 D(3) 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
JournalThe Journal of Clinical Endocrinology & Metabolism
Volume97
Issue number10
DOIs
Publication statusPublished - 1 Oct 2012

Keywords

  • aged
  • biomarkers/metabolism
  • cardiovascular diseases/mortality
  • cholecalciferol/administration & dosage
  • double-blind method
  • female
  • humans
  • middle aged
  • placebos
  • postmenopause
  • risk factors
  • risk reduction behavior
  • vitamins/administration & dosage

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    Wood, A. D., Secombes, K. R., Thies, F., Aucott, L., Black, A. J., Mavroeidi, A., Simpson, W. G., Fraser, W. D., Reid, D. M., & Macdonald, H. M. (2012). Vitamin D3 supplementation has no effect on conventional cardiovascular risk factors: a parallel-group, double-blind, placebo-controlled RCT. The Journal of Clinical Endocrinology & Metabolism, 97(10), 3557-3568. https://doi.org/10.1210/jc.2012-2126