Alternative iron replacement therapy in patients with iron deficiency after weight loss surgery.
- Conditions
- Iron deficiency occurs after bariatric surgery due to change of anatomical and physiological conditions:Bariatric surgery reduces gastric acid and delays the mix of chyme and biliopancreatic juice, patients are less likely to tolerate red meat (main source of haem iron). Non-haem iron is mainly absorbed in the duodenum and jejunum which are bypassed when performing RYGB. Patients may suffer from fatigue, weakness, tachycardia, heartfailure and loss of mental and physical performance.Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2021-001953-30-AT
- Lead Sponsor
- Verein zur Förderung der Wissenschaft und Forschung an der 1. Med. Abteilung der Klinik Landstraße
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 60
Age between 18 and 60 years
Iron deficiency with hemoglobin level >8mg/dl, that developed in the post-operative period after sleeve gastrectomy or roux-en-Y gastric bypass
Ferritin <50µg/dl
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 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Preoperative hemoglobin levels <10mg/dl (Anemia of any cause)
Preoperative MCV-values over 105 fl
Current carcinoma
Gastric or duodenal ulcer (within the last three months)
Current pregnancy or breast-feeding
Copper deficiency
Inflammation (CRP > 0,5mg/dl), Acute infections, Chronic inflammatory diseases (f.ex. rheumatoid arthritis)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method