Patients who are eligible for a primary Roux- en -Y gastric bypass and who have no irondificiency
Conditions
Interventions
Trade Name: Ferrous fumarate
Product Name: ferrous fumarate 200mg
Pharmaceutical Form: Tablet
Trade Name: Losferron
Product Name: losferron
Pharmaceutical Form: Effervescent tablet
Sponsors
Rijnstate
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who are eligible for a primary Roux- en -Y gastric bypass and havee no pre-existing iron deficiency (serum ferritin of 20-200 micrograms / L), aged between 18-65 years. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 24 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -bloodtransfusion one month before and in the study period -the use of ironcontaining nutritional supplements, except our standardized multivitamin supplements. -decreased function of the kidney with a GFR of < 30ml/min and/or serum kreatinin below 50micromol/L -Hb < 7,4 mmol/L in females and Hb < 8.4mmol/L in males -accumulation of iron - iron disaeses - hypersensitivity for one of the medicinal products - psychiatric illness -pregnancy
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Analyse if failure of oral ironsuppletion is predictable at baseline (T=0) in the absorption test;Timepoint(s) of evaluation of this end point: One month after surgery | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of the disturbance of ironabsorption after a RYGB, which leads to a insufficient treatment of oral ironsuppletion. ;Secondary Objective: Analyse if failure of oral ironsuppletion is predictable at baseline (T=0) in the absorption test. ;Primary end point(s): Iron values in the blood before and 1,2,3,4,5 and 6 hours after the administration of oral ironreplacement in micrograms / dl. The difference between pre- and postoperative absorptionvalues;Timepoint(s) of evaluation of this end point: One month before surgery and one month after surgery | — |
Countries
Netherlands
Contacts
Public ContactWendy Schijns
Rijnstate
Outcome results
None listed