Clinical trial NCT06350955: IV Iron-induced Hypophosphatemia After RYGB
Official title: Intravenous Iron-induced Hypophosphatemia in Patients With Roux-en-Y Gastric Bypass: a Single-blind, Randomized Clinical Trial Comparing Iron Isomaltoside (Monofer®) and Ferric Carboxymaltose (Ferinject®)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Hypophosphatemia
Roux-en-Y Gastric Bypass
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2024-04-08
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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®).


Eligibility criteria: 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.

Primary outcomes:
measure: incidence of hypophosphatemia in RYGB patients treated with intravenous iron
timeFrame: day 14 ± 2, 21 ± 2 and 28 ± 2
Secondary outcomes:
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: CHUV
state: Vaud
Study officials:
References: