Optimizing Iron Suppletion After Roux-en-Y Gastric Bypass

Phase 4

Completed

• Conditions: Iron Deficiency
• Interventions: Drug: Iron(III)carboxymaltose; Drug: Ferrous fumarate; Drug: Ferrous gluconate

• Registration Number: NCT02271997
• Lead Sponsor: Rijnstate Hospital

Brief Summary

Multicentre randomized controlled trial to evaluate the optimal treatment for patients who developed an iron deficiency after Roux-en-Y Gastric bypass.

Detailed Description

Morbid obesity is worldwide a still growing problem. The number of bariatric procedures are still increasing with 9000 bariatric operations in 2009. The golden standard is the Roux-en-Y Gastric bypass (RYGB). The RYGB ensures an excess weight loss of 60-70% in our hospital.

Unfortunately vitamin and mineral deficiencies are a consequence from RYGB. Iron deficiency occurs in 14-66% in the first two years after surgery. Worldwide there are three most used options of treatment for this: treatment with ferrous fumarate, ferrous gluconate and intravenous injection of Ferinject.

Our goal is to determine which treatment is the most effective to normalize ferritin values in the blood and which treatment is the most cost-effective one after a RYGB.

Study Timeline

• Study First Submitted: 2014-10-20
• Study First Submitted QC: 2014-10-20
• Study First Posted: 2014-10-22
• Study Start: 2014-12-04
• Primary Completion: 2017-06-06
• Study Completion: 2017-06-06
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-16
• Last Update Posted: 2019-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

• all women who underwent a Roux-en-Y gastric bypass and developed an iron deficiency postoperatively (ferritin<20microgram/L)

Read More

Exclusion Criteria

• iron deficiency peroperative, blood transfusions during study period, iron containing nutritional supplements except the standard multivitamins after bariatric surgery, decreased renal failure, excessive blood loss due to menstruation, anemia not caused by iron deficiency, accumulation of iron, hypersensitivity for noe of the medicinal products, psychiatric illness, pregnancy

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Iron(III)carboxymaltose	Iron(III)carboxymaltose	40 patients receive a single intravenous shot of ferinject
Ferrous fumarate	Ferrous fumarate	40 patients receive ferrous fumarate 3 times a day 200mg
Ferrous gluconate	Ferrous gluconate	40 patients receive ferrous gluconate 2 times a day 695 mg

Primary Outcome Measures

Name	Time	Method
normal value serum ferritin	1 year	1 year after initiating therapy

Secondary Outcome Measures

Name	Time	Method
patients preference for oral or intravenous therapy	1 year

Trial Locations

Locations (3)

Rijnstate hospital; 🇳🇱 Arnhem, Netherlands

Rose Kruis Ziekenhuis; 🇳🇱 Beverwijk, Netherlands

OLVG West/ Sint Lucas Andreas Ziekenhuis; 🇳🇱 Amsterdam, Noord-Holland, Netherlands