Iron Absorption Trial

Study Overview
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Brief Summary
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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.

Conditions
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Iron Absorption, Bariatric Surgery, Roux- en -y Gastric Bypass

Intervention / Treatment
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* Drug: Ferrous fumarate
* Drug: Ferrous gluconate


Participation Criteria
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Eligibility Criteria
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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) 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

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

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ferrous fumarate<br>12 patients receive ferrous fumarate, 12 patients receive ferrous gluconate | Drug: Ferrous fumarate<br>* one group receives ferrous fumarate (12 patients) and one group (12 patients) receives ferrous gluconate<br>|
| Active Comparator: ferrous gluconate<br>12 patients receive ferrous fumarate and 12 patients receive ferrous gluconate | Drug: Ferrous gluconate<br>* One group receives ferrous fumarate and one group receives ferrous fumarate.<br>* Other names: Losferron;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Iron values in the blood | 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. | 1 month after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| difference in absorption between ferrous fumarate and ferrous gluconate |  | 1 month after surgery |