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Completed

NCT Number: NCT02271997

Optimizing Iron Suppletion After Roux-en-Y Gastric Bypass

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

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Key information

Conditions

Iron Deficiency Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

OLVG West/ Sint Lucas Andreas Ziekenhuis, Amsterdam, North Holland, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

Ferrous fumarate

Drug

treatment with ferrous fumarate during 1 year and 6,12,26 and 52 weeks after starting treatment iron spectrum will be measured

Ferrous gluconate

Drug

treatment with ferrous gluconate during 1 year and 6,12,26 and 52 weeks after starting treatment iron spectrum will be measured

Other names: Losferron

Iron(III)carboxymaltose

Drug

treatment with Iron(III)carboxymaltose and 6,12,26 and 52 weeks after starting treatment iron spectrum will be measured

Other names: Ferinject

Primary outcomes

  1. normal value serum ferritin

    Time frame: 1 year

    1 year after initiating therapy

Secondary outcomes

  1. patients preference for oral or intravenous therapy

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Rijnstate Hospital

Other

Registry information

Acronym: Ironsuppletion

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Oct 22, 2014
Registry last updated
Jan 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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