Iron Absorption Trial
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|ClinicalTrials.gov Identifier: NCT02228902|
Recruitment Status : Unknown
Verified May 2015 by Rijnstate Hospital.
Recruitment status was: Enrolling by invitation
First Posted : August 29, 2014
Last Update Posted : May 7, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Iron Absorption Bariatric Surgery Roux- en -y Gastric Bypass||Drug: Ferrous fumarate Drug: Ferrous gluconate||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||August 2014|
|Estimated Primary Completion Date :||June 2015|
Active Comparator: ferrous fumarate
12 patients receive ferrous fumarate, 12 patients receive ferrous gluconate
Drug: Ferrous fumarate
one group receives ferrous fumarate (12 patients) and one group (12 patients) receives ferrous gluconate
Active Comparator: ferrous gluconate
12 patients receive ferrous fumarate and 12 patients receive ferrous gluconate
Drug: Ferrous gluconate
One group receives ferrous fumarate and one group receives ferrous fumarate.
Other Name: Losferron
- Iron values in the blood [ Time Frame: 1 month after surgery ]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.
- difference in absorption between ferrous fumarate and ferrous gluconate [ Time Frame: 1 month after surgery ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02228902
|Arnhem, Netherlands, 6800WC|