IV Iron-induced Hypophosphatemia After RYGB
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-99
SponsorLucie Favre
About this trial
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
This trial does not accept healthy volunteersQualifiers
Patients over 18 years
Signed informed consent
Patients with previous RYGB surgery performed > 12 months ago
Failed response to oral iron supplementation
Disqualifiers
- 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
Trial design
Design model
Parallel
Treatments tested in this trial
Iron isomaltoside
Drugsingle dose of 500 mg iron isomaltoside
Iron Carboxymaltose
Drugsingle dose of 500 mg ferric carboxymaltose
Treatment groups
94 Participants
are divided into 2 treatment groupsGroup A: Patients with Roux-en-Y gastric bypass and iron deficiency 1Experimental treatment 1 intervention
Group B: Patients with Roux-en-Y gastric bypass and iron deficiency 2Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
incidence of hypophosphatemia in RYGB patients treated with intravenous iron
Time frame
day 14 ± 2, 21 ± 2 and 28 ± 2Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Lucie Favre
Lead sponsor
Centre Hospitalier Universitaire Vaudois
Sponsor institution
Source ClinicalTrials.gov