Ironabsorptiontrial

Conditions: Patients who are eligible for a primary Roux- en -Y gastric bypass and who have no irondificiency
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Registration Number: EUCTR2014-002323-10-NL

Lead Sponsor: Rijnstate

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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

-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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>;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

Secondary Outcome Measures

Name	Time	Method
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