drugset / Trial / NCT02228902

Iron Absorption Trial

NCT02228902

Phase 4 Completed 24 enrolled Rijnstate Hospital
Non-randomizedSingle-groupOpen-labelDiagnostic

Summary

Introduction: There are indications that the absorption of oral iron supplementation is reduced after a Roux- en -Y gastric bypass. Nevertheless, oral preparations are used as standard therapy for iron deficiency, even in patients who underwent a Roux- en -Y gastric bypass. Our goal is to evaluate if iron absorption is disturbed after a RYGB, which leads to a insufficient treatment of oral iron suppletion. Methods: an iron absorption test will be performed pre- and postoperatively in 24 patients. Two groups will be created. Preoperatively group 1 receives a daily dose of ferrous fumarate (600mg) and group 2 receives a daily dose Losferron (1390mg). Before intake of the medicines, a fasting blood sample is taken (baseline), serum iron including ferritin, transferrin and transferrin saturation will be measured. After intake of losferron/ferrous fumarate blood samples will be taken 1, 2, 3, 4, 5 and 6 hours after intake, using a drip. An increase of 80 microgram/l is representative for a sufficient iron absorption. All patients undergo a Roux- en -Y gastric bypass. Postoperatively; one month postoperatively the same absorption test will be repeated in the same patients.

Timeline

Start
2014-08
Primary completion
2015-05
Completion
2015-05-04

Drugs

EvaluationDrugModalityDoseRoute
Comparator FERROUS GLUCONATE ANHYDROUS Small molecule 1390 mg Oral
Comparator Ferrous Sulfate Diagnostic / imaging agent 600 mg Oral