Overview
The primary objective of the study is to compare the incidence of hypophosphatemia in RYGB patients treated with intravenous (IV) single dose of iron isomaltoside (Monofer®) or ferric carboxymaltose (Ferinject®).
Eligibility
Inclusion Criteria:
- Patients over 18 years
- Signed informed consent
- Patients with previous RYGB surgery performed > 12 months ago
- Failed response to oral iron supplementation
- Established diagnosis of iron deficiency by ferritin < 50 ug/l or serum ferritin ≤100ug/l and low transferrin saturation (TSAT) ≤ 30%
- Normal phosphate blood level (0.8 - 1.45 mmol/l) before infusion
- Normal magnesium blood level (0.65-1.05 mmol/l)
- Outpatient
Exclusion Criteria:
- - Patients with known hypersensitivity to iron preparation and/or anaphylaxis from any cause
- Patients for whom a treatment with one of the IV iron is contra-indicated (based on product summary of product characteristics)
- Women who are pregnant or breastfeeding
- Intention to become pregnant during the course of the study
- Renal failure, chronic kidney disease stage 3b or worse (eGFR ≤ 45 ml/min/1.73m2)
- Patients who received IV iron infusion during the last 3 months before screening
- Treatment with erythropoietin or erythropoietin-stimulation agents, red blood cell transfusion within the last 3 months prior to screening
- Alcohol or drug abuse within the past 6 months
- Planned surgical procedure within the clinical trial period
- Surgery under general anaesthesia within the last 3 months prior to screening
- Hyperparathyroidism
- Kidney transplantation
- Inability to follow study procedures or give informed consent
- Use and inability to stop from V0 to study end, phosphate supplementation (except daily multivitamin preparation recommended after bariatric surgery; the exact amount of phosphate and iron supplementation in the daily multivitamin will be recorded)
- Osteoporosis drug therapy (bisphosphonates, denosumab or selective oestrogen receptor modulators).
- Patient who refuses to be informed of incidental discoveries that may contribute to the prevention, diagnosis, and treatment of existing or probable future illnesses.