2. Materials and Methods
Inflammation
BLOOD, INFLAMMATION
The study was performed in accordance with the Helsinki Declaration and was authorized and controlled by the responsible ethics committee of St. Vincent Hospital Vienna (no. EK20/2018). Each patient signed written informed consent prior to any study procedures. The study was performed at the II Medical Department of Gastroenterology, Hepatology, Metabolic, and Inflammation Medicine at the St. Vincent Hospital of Vienna. The investigation was set as a parallel-group study with a randomized, monocentric, prospective, controlled, and unblinded design.In this open-label pilot study, a total of 20 patients were randomly assigned to one of the two study groups (group 1: ferric carboxymaltose, Blood samples were collected initially before iron substitution, as well as 2, 4, and 12 weeks after the last intravenous iron administration. At the time of reappointment, fasting blood probes were obtained from all patients between 8:00 and 10:00. These were instantly centrifuged, refrigerated, and kept at −70 °C for further analysis. All laboratory analyses were performed at the ISO 9001-approved main laboratory (Petaluma, Labcon, CA, USA) of the Vincent Group Austria at St. Vincent Hospital in Vienna, Austria.The central tendency and dispersion of continuous demographic data and serum values (for baseline and follow-up) were described as median and as first and third quartile, respectively. Differences between the study groups were assessed by two-sample t-tests with Welch correction or Mann–Whitney U tests for continuous variables, depending on distributional assumptions, as well as by χ