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Anemia (in heart failure) not treated by Vitamin D (they should have added Iron) – RCT Aug 2017

Randomized supplementation of 4000 IU vitamin D3 daily vs placebo on the prevalence of anemia in advanced heart failure: the EVITA trial.

Nutr J. 2017 Aug 23;16(1):49. doi: 10.1186/s12937-017-0270-5.

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Ernst JB1, Prokop S1, Fuchs U1, Dreier J2, Kuhn J2, Knabbe C2, Berthold HK3, Pilz S4, Gouni-Berthold I5, Gummert JF1, Börgermann J1, Zittermann A6.

  • 1 Clinic for Thoracic and Cardiovascular Surgery, Heart and Diabetes Center NRW, Ruhr University Bochum, Georgstraße 11, D-32545, Bad Oeynhausen, Germany.
  • 2 Institute for Laboratory and Transfusion Medicine, Heart- and Diabetes Center NRW, Ruhr University Bochum, Bochum, Bad Oeynhausen, Germany.
  • 3 Department of Internal Medicine and Geriatrics, Bielefeld Evangelical Hospital (EvKB), Bielefeld, Germany.
  • 4 Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Graz, Austria.
  • 5 Polyclinic for Endocrinology, Diabetes and Preventive Medicine (PEDP), University of Cologne, Cologne, Germany.
  • 6 Clinic for Thoracic and Cardiovascular Surgery, Heart and Diabetes Center NRW, Ruhr University Bochum, Georgstraße 11, D-32545, Bad Oeynhausen, Germany. azittermann at hdz-nrw.de.

BACKGROUND:
Low 25-hydroxyvitamin D (25OHD) levels (< 75 nmol/l) are inversely associated with anemia prevalence. Since anemia and low 25OHD levels are common in patients with heart failure (HF), we aimed to investigate whether vitamin D supplementation can reduce anemia prevalence in advanced HF.

METHODS:
EVITA (Effect of Vitamin D on Mortality in Heart Failure) is a randomized, placebo-controlled clinical trial in patients with initial 25OHD levels < 75 nmol/l. Participants received either 4000 IU vitamin D3 daily or a matching placebo for 36 months. A total of 172 patients (vitamin D group: n = 85; placebo group: n = 87) were investigated in this pre-specified secondary data analysis. Hemoglobin (Hb) and other hematological parameters were measured at baseline and study termination. Assessment of between-group differences in anemia prevalence and Hb concentrations was performed at study termination, while adjusting for baseline differences.

RESULTS:
In the vitamin D and placebo group, baseline proportions of patients with anemia (Hb < 12.0 g/dL in females and < 13.0 g/dL in males) were 17.2% and 10.6%, respectively (P = 0.19). At study termination, the proportion of patients with anemia in the vitamin D and placebo groups was 32.2% and 31.8%, respectively (P > 0.99). There was no between-group difference in change in the Hb concentrations (- 0.04 g/dL [95%CI:-0.53 to 0.45 g/dL]; P = 0.87). Results regarding anemia risk and Hb concentrations were similar in the subgroup of patients with chronic kidney disease (vitamin D group: n = 26; placebo group: n = 23). Moreover, results did not differ substantially when data analysis was restricted to patients with deficient baseline 25OHD levels.

CONCLUSIONS:
A daily vitamin D supplement of 4000 IU did not reduce anemia prevalence in patients with advanced HF. Data challenge the clinical relevance of vitamin D supplementation to increase Hb levels.

TRIAL REGISTRATION:
The study was registered at EudraCT (No. 2010-020793-42) and clinicaltrials.gov ( NCT01326650 ).

PMID: 28835271 DOI: 10.1186/s12937-017-0270-5


Created by admin. Last Modification: Friday August 25, 2017 13:20:21 GMT-0000 by admin. (Version 5)

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