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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
Sponsor:
Information provided by (Responsible Party):
Rijnstate Hospital

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Study Start Date : August 2014
Estimated Primary Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. difference in absorption between ferrous fumarate and ferrous gluconate [ Time Frame: 1 month after surgery ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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


Locations
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Netherlands
Rijnstate hospital
Arnhem, Netherlands, 6800WC
Sponsors and Collaborators
Rijnstate Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Rijnstate Hospital
ClinicalTrials.gov Identifier: NCT02228902     History of Changes
Other Study ID Numbers: Ironabsorption
First Posted: August 29, 2014    Key Record Dates
Last Update Posted: May 7, 2015
Last Verified: May 2015
Additional relevant MeSH terms:
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Ferrous fumarate
Ferrous gluconate
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Hematinics