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.
Conditions
Interventions
Trade Name: Lösferron forte - Brausetabletten
Product Name: Lösferron forte - Brausetabletten
Pharmaceutical Form: Effervescent tablet
INN or Proposed INN: Eisen(II)gluconat Dihydrat
Other descriptiv
Sponsors
Verein zur Förderung der Wissenschaft und Forschung an der 1. Med. Abteilung der Klinik Landstraße
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Preoperative hemoglobin levels 0,5mg/dl), Acute infections, Chronic inflammatory diseases (f.ex. rheumatoid arthritis)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main object is to ascertain whether iron absorption on patients who underwent bariatric surgery is greater when given twice the daily iron supplementation dose every other day compared to giving the daily dose on consecutive days. ;Secondary Objective: The secondary object is to compare tolerability of and therapy adherence to these two different methods of iron supplementation.;Primary end point(s): The difference of the change in hamoglobin and ferritin values before and 12 weeks after treatment compared in patients who take a single dose of iron supplements everyday and those who take twice the single dose iron supplements every second day.;Timepoint(s) of evaluation of this end point: The endpoint will be evaluated at the end of the intervention after 12 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary outcome is collected by means of 2 questionnaires. Differences in intolerances and compliance between the 2 different groups are surveyed;Timepoint(s) of evaluation of this end point: The endpoint will be evaluated at the end of the intervention after 12 weeks. | — |
Countries
Austria
Contacts
Public ContactDr. Bernhard Ludvik
Verein zur Förderung der Wissenschaft und Forschung an der 1. Med. Abteilung der Klinik Landstraße
Outcome results
None listed