Piwowarczyk, Paweł http://orcid.org/0000-0002-8529-484X
Kutnik, Paweł
Borys, Michał
Rypulak, Elżbieta
Potręć-Studzińska, Beata
Sysiak-Sławecka, Justyna
Czarnik, Tomasz
Czuczwar, Mirosław
Article History
Received: 11 February 2019
Accepted: 11 October 2019
First Online: 27 December 2019
Ethics approval and consent to participate
: This trial was registered at ClinicalTrials.gov Identifier: NCT03699371 on October 12, 2018; URL ExternalRef removed. This study will be conducted in accordance with the Declaration of Helsinki (2013) and the Regulation on Good Clinical Practice issued by Ministry of Health of Poland (2 May 2012) as well as regulation of The European Parliament and of the Council no 536/2014 on Clinical Trials (2014). All investigators involved in this study are responsible for adhering to the above ethical guidelines. Central ethical approval has been confirmed from the Ethics Committee of the Medical University of Lublin, Poland (ref approval no. KE-0254/152/2018), and we will not begin recruiting at other centres in the trial until local ethical approval has been obtained.
: Not applicable.
: MCz declares a competing interest by receiving honoraria for lectures and advisory groups on nutrition from the following pharmaceutical companies: Fresenius Medical Care, Fresenius Kabi, Nutricia, BBraun, Baxter, Nestle. Other authors declare that they have no competing interests.