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
Turrini F, Scarlini S, Giovanardi P, Messora R, Roli L, Chester J, Mussi C, Bertolotti M, Trenti T, Bondi M
Minerva cardioangiologica · 13 citations
Review labels
Neutral facts our review recorded about how this study was done. They describe method, never whether we like the result.
How it was studied
- Design
- Randomized controlled trial (indexed by PubMed)
- Studied in
- People
- Main outcome
- Health markers and function
Who paid for it
- Funding
- Funding not disclosed
Publication
- Published
- 2017-09-01 · Minerva Cardioangiol · vol. 65 · issue 6 · pp. 553–562
- Publisher
- Edizioni Minerva Medica
- Cited
- 17 citations · more than 75% of similar papers · 1.0× the field average
- References
- 0 works
- Access
- Open access (repository copy) · CC-BY
- Research areas
- Vitamin D Research Studies · Cardiovascular Function and Risk Factors · Heart Failure Treatment and Management
- Keywords
- Placebo, Medicine, Cholecalciferol, Vitamin D and neurology, Clinical endpoint, Heart failure, Internal medicine, vitamin D deficiency, Hormone, Placebo group, Randomized controlled trial, Vitamin, Gastroenterology, Endocrinology
- MeSH
- humans, vitamin d deficiency, cholecalciferol, echocardiography, exercise test, treatment outcome, follow-up studies, pilot projects, double-blind method, time factors, dietary supplements, aged, aged, 80 and over, female, male, heart failure
10 authors
From IT
- Fabrizio TurriniAzienda Unita' Sanitaria Locale Di Modena
- Stefania ScarliniAzienda Unita' Sanitaria Locale Di Modena
- Paolo GiovanardiAzienda Unita' Sanitaria Locale Di Modena
- R MessoraAzienda Unita' Sanitaria Locale Di Modena
- Laura RoliAzienda Unita' Sanitaria Locale Di Modena
- Johanna ChesterAzienda Unita' Sanitaria Locale Di Modena
Abstract
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 endpoints were echocardiographic and hormonal changes. The same targets were compared in treated and placebo groups as secondary endpoints. 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 HF 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.
Abstract via Europe PMC. Copyright remains with the authors or publisher.
Community trust
Loading…
How much do you trust this study's findings?
Comments
Sign in to rate, comment on or flag this study.Sign inSomething wrong here?
Flag this study if its information, labels or funding look wrong. An editor reviews every flag.
Sign in to rate, comment on or flag this study.Sign inEducational information about published research. Not medical advice, and not a recommendation to start or stop anything.