Bariatric Surgery Clinical Trial
Verified date | June 2020 |
Source | Rijnstate Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | Rijnstate hospital | Arnhem |
Lead Sponsor | Collaborator |
---|---|
Rijnstate Hospital |
Netherlands,
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 |
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