Iron suppletion and absorption trial

Conditions: Patients who underwent a gastric bypass and develop a irondeficiency postoperatively. The medical condition which is investigated is irondeficiency
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Registration Number: EUCTR2014-001444-37-NL

Lead Sponsor: Rijnstate Hospital

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

All patients who underwent a gastric bypass and develop a irondeficiency postoperatively. (ferritin< 20microgram/l) Age between 18 and 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 120
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

iron deficiency preoperative, bloodtransfusios during studyperiod, ironcontaining nutritional supplements except the 'standard' multivitamins after bariatric surgery, decreased renal failure, excessive menstruational blood loss, anemia not caused by irondeficiency, accumulation of iron, 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 optimal treatment for an irondeficiency after a gastric bypass (roux-en-y gastric bypass). ;Secondary Objective: What is the effective time of Ferinject <br>Evaluate the patient's preference for either oral treatment or intravenous treatment;Primary end point(s): normal value serum ferritin;Timepoint(s) of evaluation of this end point: 6 , 12, 26 en 52 weeks after starting therapy

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): enquetes with the preference for oral or intraveneus ironsuppletion.;Timepoint(s) of evaluation of this end point: 6 , 12, 26 en 52 weeks after starting therapy