Comparing Two Intravenous Iron Treatments in Adults with Roux-en-Y Gastric Bypass to Study Low Phosphate Levels

What this Trial Is About

Researchers are evaluating the occurrence of low phosphate levels hypophosphatemia in patients who have undergone Roux-en-Y gastric bypass RYGB surgery and are treated with intravenous iron. This Phase 4 clinical trial compares two types of intravenous iron treatments, iron isomaltoside Monofer and ferric carboxymaltose Ferinject, to understand their effects on phosphate levels in this specific patient group. The study is randomized and single-blind, aiming to provide insights on iron treatment safety after RYGB surgery. Participants receive a single intravenous dose of either 500 mg iron isomaltoside or 500 mg ferric carboxymaltose. The study includes two experimental groups, each receiving one of the iron formulations. The treatments are given once, and participants are monitored over time to observe changes in phosphate levels. The trial begins with screening and includes follow-up visits to assess participants biochemical responses to the iron infusion. During the study, participants undergo blood tests to measure phosphate levels at approximately 14, 21, and 28 days after treatment. Other blood levels such as magnesium and iron status are assessed before treatment. Researchers will track the incidence of hypophosphatemia and monitor participants for any adverse events. The study lasts several weeks following the single iron dose, with careful observation to understand the treatments effects on phosphate metabolism after RYGB surgery.

IV Iron-induced Hypophosphatemia After RYGB