Optimizing Iron Suppletion After Roux-en-Y Gastric Bypass

Study Overview
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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.

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

Intervention / Treatment
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* Drug: Ferrous fumarate
* Drug: Ferrous gluconate
* Drug: Iron(III)carboxymaltose


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ferrous fumarate<br>40 patients receive ferrous fumarate 3 times a day 200mg | Drug: Ferrous fumarate<br>* treatment with ferrous fumarate during 1 year and 6,12,26 and 52 weeks after starting treatment iron spectrum will be measured<br>|
| Active Comparator: Ferrous gluconate<br>40 patients receive ferrous gluconate 2 times a day 695 mg | Drug: Ferrous gluconate<br>* treatment with ferrous gluconate during 1 year and 6,12,26 and 52 weeks after starting treatment iron spectrum will be measured<br>* Other names: Losferron;|
| Active Comparator: Iron(III)carboxymaltose<br>40 patients receive a single intravenous shot of ferinject | Drug: Iron(III)carboxymaltose<br>* treatment with Iron(III)carboxymaltose and 6,12,26 and 52 weeks after starting treatment iron spectrum will be measured<br>* Other names: Ferinject;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| normal value serum ferritin | 1 year after initiating therapy | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patients preference for oral or intravenous therapy |  | 1 year |