Optimizing Iron suppletion trial after Roux- en -Y Gastric Bypass

Phase 4

• Conditions: anemia; irondeficiency; 10022958

• Registration Number: NL-OMON40886
• Lead Sponsor: Rijnstate Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 120

Inclusion Criteria

All patients who underwent a gastric bypass and developped an irondeficiency postoperatively (ferritin< 20 microfram/l) ,age between 18-65 years

Exclusion Criteria

iron deficiency preoperatve, bloodtransfusions during study period, ironcontaining nutritional supplements except the 'standard' multivitamins after bariatric surgery, decreased renal failure, excessive manstruational blood loss, anemia not caused by iron deficiency, accumulation of iron, hypersensitivity for one of the medicinal products, psychiatric illness, pregnancy.;Acute and chronic infection or other inflammationreactions, liver dysfunction.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Serum ferritin, iron, hemoglobin, transferrin saturation, and transferrin after<br /><br>6, 12 and 52 weeks after administration of ferrous fumarate, Losferron or<br /><br>Ferinjet. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Evaluate patients' preference of the route of administration : administered<br /><br>orally (ferrous fumarate / Losferron) or intravenously (Ferinject).</p><br>