Trial of IV vs Oral Iron Treatment of Iron Deficiency Anemia in the Post-Operative Bariatric Surgical Patient
Key facts
- Who runs it
- Auerbach Hematology Oncology Associates P C
- Where
- Baltimore, United StatesSee the site
- Trial code
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 104 people, planned
- Started
- 27 Feb 2020
- Planned end
- Feb 2026
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Ferumoxytol
- Saline
- Ferrous sulfate tablets
- Vitamin C
- Record updated
- 3 October 2025
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 16 criteriaShow less
Who can take part
- Aged ≥ 18 years
- 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
- 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
- Willingness to participate and signing the informed consent form
Who cannot take part
- Previous IV iron treatment for IDA
- Other iron treatment or blood transfusion within 4 weeks prior to the screening or treatment visit
- Planned elective surgery during the study
- Decompensated liver cirrhosis or active hepatitis (ALAT > 3 times upper limit of normal)
- History of multiple allergies (two or more)
- Known hypersensitivity to ferumoxytol or oral iron or any excipients in the drug products
- 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
- Serum ferritin > 400 ng/mL or transferrin saturation >40 %
- 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)
- Iron overload or disturbances in utilization of iron (e.g. hemochromatosis and hemosiderosis)
- Rheumatoid arthritis with symptoms or signs of active inflammation
- Pregnant and nursing women
Where in United States
- Auerbach Hematology and OncologyBaltimore, United StatesContact: Michael Auerbach, MDTaking people
About the trial
What the trial wants to find out
Given the limited long-term effectiveness of traditional weight loss methods, bariatric surgery is increasingly becoming the preferred option for sustained weight loss. With the ascendancy of the laparoscopic approach, the two most common procedures are the Roux-en-Y gastric bypass (RYGB) and the vertical sleeve gastrectomy (VSG).
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Because bariatric surgery decreases nutrient intake through restriction, malabsorption, or both, and given that obese patients are often malnourished even before surgery, postoperative micronutrient deficiency, particularly of iron, can be a serious complication and difficult to treat. Iron deficiency anemia has been reported to be as high as 49% in the post-bariatric surgical patient.
The current standard for correcting iron deficiency anemia in the post-operative bariatric surgical patient is oral iron supplements. However, oral iron therapy is known for its caustic effects on the gastric mucosa causing gastric irritation, nausea, epigastric discomfort and constipation. These debilitating symptoms lead to poor adherence and lower long and short-term efficacy. Furthermore, iron absorption from oral iron supplements when taken with food in patients with low iron stores ranges from 2 to 13% and without food 5 to 28%. An alternative and more effective method of iron replenishment is the use of intravenous iron. A litany of published trials, without contradiction, show marked superiority of intravenous iron in improving hemoglobin concentrations and iron parameters when compared to historical controls. Nonetheless, the current recommendations of the American Society of Metabolic and Bariatric Surgery nutritional guidelines, state that oral iron supplementation for IDA is the recommended first line of treatment. Studies are lacking that compare the efficacy of oral versus intravenous (IV) iron therapy for the treatment of IDA in the post-bariatric surgical patient.
The aim of our study is to compare two accepted treatments for iron deficiency anemia (oral ferrous sulfate and intravenous ferumoxytol) for efficacy and speed of response in the treatment of IDA in the post-operative bariatric surgical patient. In this study, 104 bariatric surgical post-operative patients will be randomly assigned 52 each to oral or 52 to a single dose IV iron treatment using double-blind procedures.
The primary outcome will be determined at 6 weeks of treatment with a follow-up at 12 months after treatment. Non-responders at 6 weeks after treatment may, if they qualify (based on inclusion/exclusion criteria), have an open-label IV iron treatment and will be followed with the same evaluations used after the first IV iron treatments.
The 2 groups in the trial
- Oral IronExisting treatment, for comparison
The subject will receive one IV infusion of ferumoxytol administered as 1020 mg over 30 minutes or an equivalent volume of normal saline. At the time of the infusion, the patient will also be given an opaque bottle, containing either vitamin C tablets or ferrous sulfate 325 mg.
Treatment: Ferumoxytol, Saline, Ferrous sulfate tablets, and Vitamin C
- IV IronExisting treatment, for comparison
The subject will receive one IV infusion of ferumoxytol administered as 1020 mg over 30 minutes or an equivalent volume of normal saline. At the time of the infusion, the patient will also be given an opaque bottle, containing either vitamin C tablets or ferrous sulfate 325 mg.
Treatment: Ferumoxytol, Saline, Ferrous sulfate tablets, and Vitamin C
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Randomized, Placebo-controlled Comparator Trial of IV vs Oral Iron Treatment of Iron Deficiency Anemia in the Post-Operative Bariatric Surgical Patient
- Record updated
- 3 October 2025