Iron Absorption Trial

Bariatric Surgery Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02228902
• Other study ID #: Ironabsorption
• Status: Completed
• Phase: Phase 4
• Start date: August 2014
• Est. completion date: May 4, 2015

Study information

• Verified date: June 2020
• Source: Rijnstate Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 4, 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery
• Iron Absorption
• Roux- en -y Gastric Bypass

Intervention

Drug:
• Ferrous fumarate
one group receives ferrous fumarate (12 patients) and one group (12 patients) receives ferrous gluconate
• Ferrous gluconate
One group receives ferrous fumarate and one group receives ferrous fumarate.

Locations

Country	Name	City	State
Netherlands	Rijnstate hospital	Arnhem

Sponsors (1)

Lead Sponsor	Collaborator
Rijnstate Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	difference in absorption between ferrous fumarate and ferrous gluconate		1 month after surgery