Ironsuppletion trial

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

Registration Number: EUCTR2014-002322-12-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 developped an irondeficiency postoperatively (ferritin< 20 microfram/l) age 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 120
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

iron deficiency preoperatve, bloodtransfusions during study period, ironcontaining nutritional supplements except the 'standard' multivitamins after bariatric surgery, decreased renal failure, excessive manstruational blood loss, anemia not caused by iron deficiency, accumulation of iron, hypersensitivity for one of the medicinal products, psychiatric illness, pregnancy.
Acute and chronic infection or other inflammationreactions, liver dysfunction.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: evaluation on teh optimal treatment for an irondificiency after a roux- en -y gastric bypass;Secondary Objective: What is the effective time of Ferinject? <br>Evaluate the patients 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 and 53 weeks after starting therapy

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): enquetes with the preferece for oral or intravenous ironsuppletion;Timepoint(s) of evaluation of this end point: 6,12,26 and 53 weeks after starting therapy