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A Journal on Heart and Vascular Diseases

Official Journal of the Italian Society of Angiology and Vascular Pathology
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Minerva Cardioangiologica 2017 May 31

DOI: 10.23736/S0026-4725.17.04340-7


language: English

Effects of cholecalciferol supplementation in patients with stable heart failure and low vitamin D levels (ECSPLOIT-D). A double-blind, randomized, placebo-controlled pilot study

Fabrizio TURRINI 1, Stefania SCARLINI 1, Paolo GIOVANARDI 1, Roberto MESSORA 1, Laura ROLI 2, Johanna CHESTER 2, Chiara MUSSI 3, Marco BERTOLOTTI 3, Tommaso TRENTI 2, Marco BONDI 1

1 Cardiovascular Medicine, Department of Internal Medicine, Nuovo Ospedale Civile Sant’Agostino Estense, AUSL Modena, Modena, Italy; 2 Department of Laboratory Medicine, Clinical Pathology-Toxicology, Nuovo Ospedale Civile Sant’Agostino Estense, AUSL Modena, Modena, Italy; 3 Department of Internal Medicine, Endocrinology, Metabolism and Geriatrics, Nuovo Ospedale Civile Sant’Agostino Estense, AUSL Modena, Modena, Italy


BACKGROUND: The aim of this study was to investigate the effects of vitamin D (VD) on the interaction among functional, echocardiographic and hormonal parameters in patients with heart failure (HF) and VD deficiency.
METHODS: In a randomized, double blind trial, 35 patients with HF and VD < 20 ng/ml, received either 300,000 U of oral cholecalciferol followed by 50,000 U/month for 6 months, or placebo treatment.
RESULTS: Changes in the 6 Minute Walking Test (6MWT) assessed at 3 and 6 months in treatment group was the primary end point. Secondary end points were echocardiographic and hormonal changes. The same targets were compared in treated and placebo groups as secondary end points. In the treatment group the 6MWT improved at 3 (from 210 ± 104 mt to 225 ± 94 mt; P=0.033) but not at 6 months (from 210 ± 104 mt to 217 ± 94 mt; P=0.288) while PTH dropped at 3 (from 76.8 ± 50.5 to 50.2 ± 20.3 pg/ml; P=0.025), but not at 6 months. 6MWT improvement was negatively related to baseline VD levels. Variation in 6MWT did not significantly differ among groups at 3 (13.6±23.3 vs 3.6±17.3; P 0.175) and 6 months (12.1±31.4 vs 0.2±23.2; P 0.225). Left atrial size increased in the placebo group (from 50.8 ± 20.7 to 61.7 ± 36.0 ml/m2; P=0.010). Other hormonal parameters remained unchanged.
CONCLUSIONS: In summary, the treatment of VD deficiency in patients with heart failure improved 6MWT after 3 months along with a decrease in PTH levels. However when compared with the placebo arm, treatment of VD deficiency did not influence the final outcomes.

KEY WORDS: Heart failure - Vitamin D deficiency – Six minute walking test

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