Heart Failure not helped by Vitamin D (several strange things about the trial) – RCT

Created May 2017

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 May 12. doi: 10.1093/eurheartj/ehx235. [Epub ahead of print]

Zittermann A1 , Ernst JB1, Prokop S1, Fuchs U1, Dreier J2, Kuhn J2, Knabbe C2, Birschmann

I2, Schulz U1, Berthold HK3, Pilz S4, Gouni-Berthold I5, Gummert JF1, Dittrich M6, Börgermann J1.

1. This RCT did NOT find a benefit Many strange things 1. The RCT listing only mentions Ergocalciferols, but not D3, yet the publication says it used D3 1. More that half of the people decided to not participate in the RCT. A study has found serious problems with RCT results when so many did not participate 1. This RCT selected only those people with chronic heart failure (80% had pacemakers), not the general public. Perhaps people with chronic heart failure are more likely to have poor a Vitamin D Receptor than the healthy public, and thus would need significantly higher levels of Vitamin D (> 50 ng?) to get enough Vitamin D to their heart cells. 1. The average vitamin D level achieved was 40 ng – where Vitamin D starts to help the healthy * RCT failed to compare results for those < 40 ng and > 40 ng 1. About 45% of the participants did not continue to take the vitamin D for the entire RCT - were those people healthier? --- 1. See also VitaminDWiki 1. # Items in both categories Cardiovascular and Intervention are listed here: {category} 1. Cardiovascular category in VitaminDWiki starts with the following {include} 1. A few of the Meta-analyses of Vitamin D and Cardiovascular problems * Cardiovascular deaths 12 percent less likely if have 10 ng more vitamin D – meta-analysis March 2017 * C-reactive protein (heart disease marker) reduced by vitamin D – meta-analysis 2014, 2019 1. See also Vitamin D Council on this study

AIMS:

Circulating 25-hydroxyvitamin D (25OHD) levels <75 nmol/L are associated with a nonlinear increase in mortality risk. Such 25OHD levels are common in heart failure (HF). We therefore examined whether oral vitamin D supplementation reduces mortality in patients with advanced HF.

METHODS AND RESULTS:

Four hundred HF patients with 25OHD levels <75 nmol/L were randomized to receive 4000 IU vitamin D daily or matching placebo for 3 years. Primary endpoint was all-cause mortality.

Key secondary outcome measures included, hospitalization, resuscitation, mechanical circulatory support (MCS) implant, high urgent listing for heart transplantation, heart transplantation, and hypercalcaemia.

Initial 25OHD levels were on average <40 nmol/L, remained around 40 nmol/L in patients assigned to placebo and plateaued around 100 nmol/L in patients assigned to vitamin D.

Mortality was not different in patients receiving vitamin D (19.6%; n = 39) or placebo (17.9%; n = 36) with a hazard ratio (HR) of 1.09 [95% confidence interval (CI): 0.69-1.71; P = 0.726].

The need for MCS implant was however greater in patients assigned to vitamin D (15.4%, n = 28) vs. placebo [9.0%, n = 15; HR: 1.96 (95% CI: 1.04-3.66); P = 0.031].

Other secondary clinical endpoints were similar between groups. The incidence of hypercalcaemia was 6.2% (n = 10) and 3.1% (n = 5) in patients receiving vitamin D or placebo (P = 0.192).

CONCLUSION:

A daily vitamin D dose of 4000 IU did not reduce mortality in patients with advanced HF but was associated with a greater need for MCS implants. Data indicate caution regarding long-term supplementation with moderately high vitamin D doses.

Trial listing: NCT01326650

PMID: 28498942 DOI: 10.1093/eurheartj/ehx235   Publisher wants $42 for the PDF

Tags: Cardiovascular Intervention