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J Clin Endocrinol Metab. 2012 Oct;97(10):3557-68. doi: 10.1210/jc.2012-2126. Epub 2012 Aug 3.

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

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  • 1School of Medicine and Dentistry, Health Sciences Building, University of Aberdeen, and Grampian Osteoporosis Service, Woolmanhill Hospital, Foresterhill, Aberdeen AB25 2ZD, United Kingdom.

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.

PMID:
22865902
[PubMed - indexed for MEDLINE]
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