Actively Recruiting
IV Iron-induced Hypophosphatemia After RYGB
Led by Lucie Favre · Updated on 2024-08-20
94
Participants Needed
1
Research Sites
108 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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®).
CONDITIONS
Official Title
IV Iron-induced Hypophosphatemia After RYGB
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 C=100 ug/l and low transferrin saturation (TSAT) C= 30%
- Normal phosphate blood level (0.8 - 1.45 mmol/l) before infusion
- Normal magnesium blood level (0.65-1.05 mmol/l)
- Outpatient
You will not qualify if you...
- Patients with known hypersensitivity to iron preparation and/or anaphylaxis from any cause
- Patients for whom treatment with one of the IV iron is contra-indicated
- 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 C= 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 phosphate supplementation (except daily multivitamin after bariatric surgery)
- Osteoporosis drug therapy (bisphosphonates, denosumab or selective oestrogen receptor modulators)
- Patient who refuses to be informed of incidental discoveries relevant to health
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
CHUV
Lausanne, Canton of Vaud, Switzerland, 1003
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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