A Phase 4 interventional study of Ferrous fumarate and Ferrous gluconate in Iron Absorption, Bariatric Surgery and Roux- en -y Gastric Bypass, sponsored by Rijnstate Hospital. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-11.
Sponsored by Rijnstate Hospital · Phase 4, Interventional, and Diagnostic
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.
Rijnstate Hospital is the lead sponsor of 127 studies on the registry; 14 are open to participants now.
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Exclusion Criteria:
12 patients receive ferrous fumarate, 12 patients receive ferrous gluconate
Drug: Ferrous fumarate
12 patients receive ferrous fumarate and 12 patients receive ferrous gluconate
Drug: Ferrous gluconate
one group receives ferrous fumarate (12 patients) and one group (12 patients) receives ferrous gluconate
One group receives ferrous fumarate and one group receives ferrous fumarate.
Also known as: Losferron
Iron values in the blood
Iron levels in teh blood will be measured before and 1,2,3,4,5 and 6 hours after the administration of oral iron replacement in micrograms / dl. This will take place before surgery and one month after surgery. The primary outcome is de difference between iron values pre- and postoperatively.
Time frame: 1 month after surgery
difference in absorption between ferrous fumarate and ferrous gluconate
Time frame: 1 month after surgery
This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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Rijnstate Hospital