NCT02228902

Iron Absorption Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Rijnstate Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Iron Absorption
• Bariatric Surgery
• Roux- en -y Gastric Bypass

Interventions

Type	Name	Description
DRUG	Ferrous fumarate	one group receives ferrous fumarate (12 patients) and one group (12 patients) receives ferrous gluconate
DRUG	Ferrous gluconate	One group receives ferrous fumarate and one group receives ferrous fumarate.

Timeline

• Start date: 2014-08-01
• Primary completion: 2015-05-01
• Completion: 2015-05-04
• First posted: 2014-08-29
• Last updated: 2020-06-11

Locations

1 site across 1 country: Netherlands