Vitamin D does not reduce mortality in adults with advanced heart failure

Clinical Question

Is supplemental vitamin D beneficial for adults with advanced heart failure?

Bottom Line

Daily supplementation with 4000 IU vitamin D did not reduce all-cause mortality or hospitalization rates in adults with advanced heart failure and low baseline vitamin D levels. In an analysis of secondary outcomes, the need for mechanical circulatory support implantation was significantly increased in the vitamin D group compared with placebo group. (LOE = 1b)

Reference

Zittermann A, Ernst JB, Prokop S, et al. Effect of vitamin D on all-cause mortality in heart failure (EVITA): A 3-year randomized clinical trial with 4000 IU vitamin D daily. Eur Heart J 2017;38(29):2279-2286.  [PMID:28498942]

Study Design

Randomized controlled trial (double-blinded)

Funding

Industry + govt

Allocation

Concealed

Setting

Outpatient (specialty)

Synopsis

Observational studies have shown a greater risk of death in adults with advanced heart failure and low 25-hydroxy vitamin D serum levels. These investigators identified adults, aged 18 to 79 years, with heart failure classified as New York Heart Association functional heart failure class II or higher. Eligible patients randomly received (concealed allocation assignment) either 4000 IU vitamin D3 daily or matched placebo. Patients, their treating clinicians, and individuals who assessed outcomes all remained masked to treatment group assignment. At baseline 41% of patients had 25-hydroxy vitamin D levels less than 30 nmol/L and an additional 38% had levels between 30 nmol/L and 50 nmol/L. Complete follow-up occurred for 100% of patients at 3 years. Using intention-to-treat analysis, there was no significant difference in all-cause mortality between the vitamin D group and the placebo group (19.6% vs 17.9%, respectively). The levels of 25-hydroxy vitamin D plateaued near 100 nmol/L in the treatment group and remained near 40 nmol/L in the placebo groups. Secondary analysis of various outcomes also found no significant differences in hospitalization rates or causes of hospitalization, but there was a significantly increased need for mechanical circulatory support implantation in the vitamin D group compared with the placebo group (15% vs 9%, respectively; number needed to treat to harm = 15.1; 95% CI 7.8 - 201.5). Analyses of outcomes in subgroups based on initial 25-hydroxy vitamin D serum levels did not differ significantly from the results of the entire study group.

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