Randomized controlled trial2016Open access

Effects of Vitamin D on Cardiac Function in Patients With Chronic HF: The VINDICATE Study

Witte KK, Byrom R, Gierula J, Paton MF, Jamil HA, Lowry JE, Gillott RG, Barnes SA, Chumun H, Kearney LC, Greenwood JP, Plein S, Law GR, Pavitt S, Barth JH, Cubbon RM, Kearney MT

Journal of the American College of Cardiology · 161 citations

How it was studied

Design
Randomized controlled trial (indexed by PubMed)
Studied in
People
Main outcome
Health markers and function

Who paid for it

Funding
Independent funding
Government
National Institute for Health and Care Research
Nonprofit
British Heart Foundation
University or hospital
University of Leeds
Government
National Institutes of Health
Government
Medical Research Council
Government
National Institute for Health Research (NIHR)
Grants
British Heart Foundation (RG/09/010/28087); British Heart Foundation (FS/12/80/29821); National Institute for Health and Care Research (HCS DRF-2014-05-006); Medical Research Council (MR/J00281X/1); British Heart Foundation (FS/10/028/28252)

Based on 6 listed funder(s).

Publication

Published
2016-04-04 · J Am Coll Cardiol · vol. 67 · issue 22 · pp. 2593–2603
Publisher
Elsevier BV
Cited
228 citations · more than 100% of similar papers · 22.8× the field average
Impact
Top 10% most cited in its field
References
45 works
Access
Open access (hybrid journal) · CC-BY
Research areas
Vitamin D Research Studies · GDF15 and Related Biomarkers · Cardiac Fibrosis and Remodeling
Keywords
Medicine, Vitamin D and neurology, Cholecalciferol, Ejection fraction, Heart failure, Internal medicine, Clinical endpoint, Vitamin, vitamin D deficiency, Placebo, Cardiology, Confidence interval, Cardiac function curve, Endocrinology, Clinical trial, Pathology
MeSH
heart ventricles, humans, ventricular dysfunction, left, cholecalciferol, calcifediol, calcitriol, vitamins, magnetic resonance imaging, cine, echocardiography, stroke volume, double-blind method, systole, ventricular remodeling, aged, middle aged, female, male, heart failure, walk test

17 authors

From GB

  • Klaus Karl Witte · correspondingUniversity of Leeds; Leeds Beckett University
  • Rowena ByromUniversity of Leeds
  • John GierulaUniversity of Leeds
  • Maria F. PatonUniversity of Leeds
  • Haqeel A. JamilUniversity of Leeds
  • Judith E. LowryUniversity of Leeds

Abstract

Background

Patients with chronic heart failure (HF) secondary to left ventricular systolic dysfunction (LVSD) are frequently deficient in vitamin D. Low vitamin D levels are associated with a worse prognosis.

Objectives

The VINDICATE (VitamIN D treatIng patients with Chronic heArT failurE) study was undertaken to establish safety and efficacy of high-dose 25 (OH) vitamin D3 (cholecalciferol) supplementation in patients with chronic HF due to LVSD.

Methods

We enrolled 229 patients (179 men) with chronic HF due to LVSD and vitamin D deficiency (cholecalciferol <50 nmol/l [<20 ng/ml]). Participants were allocated to 1 year of vitamin D3 supplementation (4,000 IU [100 μg] daily) or matching non-calcium-based placebo. The primary endpoint was change in 6-minute walk distance between baseline and 12 months. Secondary endpoints included change in LV ejection fraction at 1 year, and safety measures of renal function and serum calcium concentration assessed every 3 months.

Results

One year of high-dose vitamin D3 supplementation did not improve 6-min walk distance at 1 year, but was associated with a significant improvement in cardiac function (LV ejection fraction +6.07% [95% confidence interval (CI): 3.20 to 8.95; p < 0.0001]); and a reversal of LV remodeling (LV end diastolic diameter -2.49 mm [95% CI: -4.09 to -0.90; p = 0.002] and LV end systolic diameter -2.09 mm [95% CI: -4.11 to -0.06 p = 0.043]).

Conclusions

One year of 100 μg daily vitamin D3 supplementation does not improve 6-min walk distance but has beneficial effects on LV structure and function in patients on contemporary optimal medical therapy. Further studies are necessary to determine whether these translate to improvements in outcomes. (VitamIN D Treating patIents With Chronic heArT failurE [VINDICATE]; NCT01619891).

Abstract via Europe PMC. Copyright remains with the authors or publisher (CC BY).

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