Intravenous iron-induced hypophosphatemia in patients who have undergone Roux-en-Y gastric bypass: a single-blind randomized clinical trial comparing iron isomaltoside (Monofer®) and ferric carboxymaltose (Ferinject®)
Summary description of the study
Patients who are followed up after bariatric surgery occasionally require iron infusion. A side effect of this infusion is hypophosphatemia (low phosphate levels in the blood). Symptoms of hypophosphatemia include general weakness and fatigue. In very rare cases, this drop in phosphate levels can cause symptoms of muscle weakness or breathing difficulties. We propose to test two formulations of intravenous iron for the potential occurrence of a drop in phosphate levels. A total of 4 visits to our clinic will be necessary (one for the infusion and 3 subsequently on a weekly basis for blood and urine tests). An electrocardiogram and a grip strength test (strength of your hand flexion) will also be performed.
(BASEC)
Intervention under investigation
Patients who require iron infusion will receive iron isomaltoside (Monofer®) or ferric carboxymaltose (Ferinject®). The patient will not know which type of iron they received. A total of 4 visits to our clinic will be necessary (one for the infusion and 3 weekly for blood and urine tests).
(BASEC)
Disease under investigation
Hypophosphatemia after iron infusion in patients who have undergone bariatric surgery (Roux-en-Y gastric bypass)
(BASEC)
1. >12 months post bariatric surgery (RYGB) 2. ferritin <50 ug/l 3. Failure or intolerance to oral iron supplementation (BASEC)
Exclusion criteria
1. Patients with known hypersensitivity to the iron preparation and/or anaphylaxis, regardless of the cause. 2. Pregnant or breastfeeding women 3. Patients who have received an intravenous iron infusion in the last 3 months. (BASEC)
Trial sites
Lausanne
(BASEC)
Sponsor
CHUV
(BASEC)
Contact
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Vaud
(BASEC)
Date of authorisation
21.12.2023
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
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®) (BASEC)
Academic title
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Public title
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Disease under investigation
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Intervention under investigation
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Type of trial
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Trial design
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Inclusion/Exclusion criteria
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Primary and secondary end points
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Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
not available
Secondary trial IDs
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Results-Individual Participant Data (IPD)
not available
Further information on the trial
not available
Results of the trial
Results summary
not available
Link to the results in the primary register
not available