Optimizing Iron Suppletion After Roux-en-Y Gastric Bypass

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-04

Study Completion Date

2017-06-06

Brief Summary

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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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Detailed Description

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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.

Conditions

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Iron Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ferrous fumarate

40 patients receive ferrous fumarate 3 times a day 200mg

Group Type ACTIVE_COMPARATOR

Ferrous fumarate

Intervention Type 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

40 patients receive ferrous gluconate 2 times a day 695 mg

Group Type ACTIVE_COMPARATOR

Ferrous gluconate

Intervention Type DRUG

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

Iron(III)carboxymaltose

40 patients receive a single intravenous shot of ferinject

Group Type ACTIVE_COMPARATOR

Iron(III)carboxymaltose

Intervention Type DRUG

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

Interventions

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Ferrous fumarate

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

Intervention Type DRUG

Ferrous gluconate

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

Intervention Type DRUG

Iron(III)carboxymaltose

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

Intervention Type DRUG

Other Intervention Names

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Losferron Ferinject

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No