Iron Absorption Trial

Phase 4

Completed

• Conditions: Iron Absorption; Bariatric Surgery; Roux- en -y Gastric Bypass
• Interventions: Drug: Ferrous fumarate; Drug: Ferrous gluconate

• Registration Number: NCT02228902
• Lead Sponsor: Rijnstate Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-08-13
• Study First Submitted QC: 2014-08-27
• Study First Posted: 2014-08-29
• Primary Completion: 2015-05
• Study Completion: 2015-05-04
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-08
• Last Update Posted: 2020-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• patients who are eligible for a primary Roux- en -Y gastric bypass and who have no pre-existing iron deficiency (serum ferritin between 20-200 micrograms/L)

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Exclusion Criteria

• blood transfusion one month before ans in the study period. The use of iron containing nutritional supplements, except our standardized multivitamin supplements. Decreased function of the kidney with a GFR of < 30ml/min and a serum creatinin below 50 micromol/L. Hb< 7.4 mmol/L in females en Hb< 8.4 mmol/L in males. Accumulation of iron. Hypersensitivity for ons of the medicinal products. Psychiatric illness. Pregnancy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ferrous fumarate	Ferrous fumarate	12 patients receive ferrous fumarate, 12 patients receive ferrous gluconate
ferrous gluconate	Ferrous gluconate	12 patients receive ferrous fumarate and 12 patients receive ferrous gluconate

Primary Outcome Measures

Name	Time	Method
Iron values in the blood	1 month after surgery	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.

Secondary Outcome Measures

Name	Time	Method
difference in absorption between ferrous fumarate and ferrous gluconate	1 month after surgery

Trial Locations

Locations (1)

Rijnstate hospital; 🇳🇱 Arnhem, Netherlands