Design and rationale of a multicentre, randomised, double-blind, placebo-controlled clinical trial to evaluate the effect of vitamin D on ventricular remodelling in patients with anterior myocardial infarction: the VITamin D in Acute Myocardial Infarction (VITDAMI) trial.

What Was Tested

Researchers studied Vitamin D, K2, Magnesium and Zinc in this randomized controlled trial publication.

Change in LV end-diastolic and end-systolic volumes, ejection fraction, LV mass, diastolic function, sphericity index and size of fibrotic area; endothelial function; plasma levels of aminoterminal fragment of B-type natriuretic peptide, galectin-3 and monocyte chemoattractant protein-1; levels of calcidiol (VD metabolite) and other components of mineral metabolism (fibroblast growth factor-23 (FGF-23), the soluble form of its receptor klotho, parathormone and phosphate).

Differences in the effect of VD will be investigated according to the plasma levels of FGF-23 and klotho.

Treatment safety and tolerability will be assessed.

Why It Was Studied

Anterior ST-elevation acute myocardial infarction (STEMI) is the best human model to study the effect of treatments on LV remodelling.

This trial has been approved by the corresponding Institutional Review Board (IRB) and National Competent Authority (Agencia Española de Medicamentos y Productos Sanitarios (AEMPS)).

Who Took Part

The abstract describes 144 patients taking part.

The age groups tagged for this paper are adults, middle-aged adults, older adults and people over 80, both men and women.

How the Study Was Run

In design terms this was a randomized, double-blind, placebo-controlled and multicenter study.

Random assignment meant chance, not the researchers, decided who got Vitamin D, K2, Magnesium and Zinc and who got the comparison, which limits bias.

As a double-blind Vitamin D, K2, Magnesium and Zinc study, the assignments were hidden from both participants and investigators until the end.

Some patients received a placebo instead of Vitamin D, K2, Magnesium and Zinc, giving a reference point.

More than one site took part, so the patients came from several places.

What Was Measured

PubMed files the paper under topics including Angioplasty, Balloon, Coronary, Biomarkers, Calcifediol, Chemokine CCL2, Fibroblast Growth Factor-23, Heart and Magnetic Resonance Imaging.

The authors tagged it with the keywords Vitamin D, acute myocardial infarction, cardiac magnetic resonance imaging and remodeling.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Vitamin D, K2, Magnesium and Zinc in 144 patients.

The publication is from 2016 (BMJ open), a journal based in England.

More context: the Vitamin D, K2, Magnesium and Zinc compound page, all human trials.