Comparing IV and oral iron treatments for anemia after bariatric surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of intravenous (IV) iron treatment compared to oral iron supplements in patients suffering from iron deficiency anemia following bariatric surgery, specifically Roux-en-Y gastric bypass and vertical sleeve gastrectomy. Given the high prevalence of iron deficiency anemia in post-operative bariatric patients, the study aims to determine which method provides better outcomes in correcting anemia. Participants will be monitored for improvements in iron levels and overall health after receiving either treatment. The trial includes adults who are at least three months post-surgery and meet specific criteria for iron deficiency.

Why it matters

Who can join: the full rules

Inclusion criteria:

1. Aged ≥ 18 years
2. Patients who have undergone a Roux-en Y Gastric Bypass or Vertical Sleeve Gastrectomy and are at least 3 months or more out from surgery.
3. Iron deficiency anemia defined as iron deficient with either ferritin\<30 mcg/l, TSAT\<20%, or anemia with Hgb\<13 g/dL for both males and females.
4. Willingness to participate and signing the informed consent form.

Exclusion criteria:

1. Iron overload or disturbances in utilization of iron (e.g. hemochromatosis and hemosiderosis)
2. Decompensated liver cirrhosis or active hepatitis (ALAT \> 3 times upper limit of normal)
3. Serum ferritin \> 400 ng/mL or transferrin saturation \>40 %
4. Active acute or chronic infections (assessed by clinical judgment that may be indicated by White Blood Cells (WBC) and C-Reactive Protein (CRP) when these are available)
5. Rheumatoid arthritis with symptoms or signs of active inflammation
6. Pregnant and nursing women
7. History of multiple allergies (two or more)
8. Known hypersensitivity to ferumoxytol or oral iron or any excipients in the drug products
9. Previous IV iron treatment for IDA
10. Other iron treatment or blood transfusion within 4 weeks prior to the screening or treatment visit
11. Planned elective surgery during the study
12. Any other medical condition that, in the opinion of Investigator, may cause the subject to be unsuitable for the completion of the study or place the subject at potential risk from being in the study, e.g. a malignancy, uncontrolled hypertension, unstable ischemic heart disease, or uncontrolled diabetes mellitus

Where it's running

• Auerbach Hematology and Oncology
  Baltimore, Maryland, United States Recruiting

Study contacts

• Study coordinator: Michael Auerbach, MD
• Email: mauerbachmd@abhemonc.com
• Phone: 4107804050

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.