IV Iron-induced Hypophosphatemia After RYGB
- Conditions
- HypophosphatemiaRoux-en-Y Gastric Bypass
- Registration Number
- NCT06350955
- Lead Sponsor
- Lucie Favre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 94
Inclusion Criteria:<br><br> - Patients over 18 years<br><br> - Signed informed consent<br><br> - Patients with previous RYGB surgery performed > 12 months ago<br><br> - Failed response to oral iron supplementation<br><br> - Established diagnosis of iron deficiency by ferritin < 50 ug/l or serum ferritin<br> =100ug/l and low transferrin saturation (TSAT) = 30%<br><br> - Normal phosphate blood level (0.8 - 1.45 mmol/l) before infusion<br><br> - Normal magnesium blood level (0.65-1.05 mmol/l)<br><br> - Outpatient<br><br>Exclusion Criteria:<br><br> - <br><br> - Patients with known hypersensitivity to iron preparation and/or anaphylaxis<br> from any cause<br><br> - Patients for whom a treatment with one of the IV iron is contra-indicated (based on<br> product summary of product characteristics)<br><br> - Women who are pregnant or breastfeeding<br><br> - Intention to become pregnant during the course of the study<br><br> - Renal failure, chronic kidney disease stage 3b or worse (eGFR = 45 ml/min/1.73m2)<br><br> - Patients who received IV iron infusion during the last 3 months before screening<br><br> - Treatment with erythropoietin or erythropoietin-stimulation agents, red blood cell<br> transfusion within the last 3 months prior to screening<br><br> - Alcohol or drug abuse within the past 6 months<br><br> - Planned surgical procedure within the clinical trial period<br><br> - Surgery under general anaesthesia within the last 3 months prior to screening<br><br> - Hyperparathyroidism<br><br> - Kidney transplantation<br><br> - Inability to follow study procedures or give informed consent<br><br> - Use and inability to stop from V0 to study end, phosphate supplementation (except<br> daily multivitamin preparation recommended after bariatric surgery; the exact amount<br> of phosphate and iron supplementation in the daily multivitamin will be recorded)<br><br> - Osteoporosis drug therapy (bisphosphonates, denosumab or selective oestrogen<br> receptor modulators).<br><br> - Patient who refuses to be informed of incidental discoveries that may contribute to<br> the prevention, diagnosis, and treatment of existing or probable future illnesses.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method incidence of hypophosphatemia in RYGB patients treated with intravenous iron
- Secondary Outcome Measures
Name Time Method