Hypophosphatemia, Roux-en-Y Gastric Bypass
Conditions
Brief summary
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®).
Interventions
single dose of 500 mg iron isomaltoside
single dose of 500 mg ferric carboxymaltose
Sponsors
Lucie Favre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| incidence of hypophosphatemia in RYGB patients treated with intravenous iron | day 14 ± 2, 21 ± 2 and 28 ± 2 |
Countries
Switzerland
Outcome results
None listed