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CompletedPhase 3

Intravenous Iron Versus Oral Iron for the Treatment of Iron Deficiency Anemia

Key facts

Who runs it
Arrowhead Regional Medical Center
Where
Colton, United StatesSee the site
Trial code
Status
Completed
Phase
Phase 3
People taking part
518 people enrolled
Started
21 Nov 2023
Ended
30 Oct 2026
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Venofer 200 MG Per 10 ML Injection
  • Ferrous sulfate
Record updated
9 November 2026

Who can take part

Age
18 years and older
Sex
Women only
Healthy volunteers
Can take part

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

  • Age > 18 years of age
  • Ferritin level < 30 ng/mL
  • Single gestation
  • 14 0/7 to 34 6/7 weeks of gestation
  • Plan to deliver at Arrowhead Regional Medical Center (ARMC)

Who cannot take part

  • Acute liver/kidney disease
  • Active infections
  • Known hematological malignancy
  • Other causes of anemia such as alpha/beta thalassemia, sickle cell disease, Folate/B12 deficiency, and anemia of chronic diseases
  • Known hypersensitivity to IV iron
  • Maternal age < 18 years of age
  • Hgb < 7
  • Incarcerated patients
  • Multifetal gestation
  • Severe symptoms of anemia requiring blood transfusion

Where in United States

  • Arrowhead Regional Medical CenterColton, United States

About the trial

What the trial wants to find out

This study aims to assess whether administering intravenous iron early in pregnancy, compared to standard oral iron treatment, can enhance hemoglobin levels before delivery and reduce the need for blood transfusions in patients with iron deficiency anemia. Patients diagnosed with iron deficiency anemia were randomly assigned to receive either oral or intravenous iron. Before treatment initiation, patients completed a symptom questionnaire baseline hemoglobin, and ferritin levels were measured. Follow-up visits occurred four weeks later and at 24 to 28 weeks gestation, involving reassessment of symptoms, laboratory testing, and monitoring of treatment adherence. Final hemoglobin levels were determined before delivery, and data on the need for blood transfusion at delivery were recorded.

The 2 groups in the trial

  • Intravenous ironExisting treatment, for comparison

    Venofer 200 mg will be given every other day until the patient reaches their calculated in deficit dose. The does of IV iron will be calculated according to the Ganzoni formula: total iron dose (mg) = body weight (kg) x (target Hgb - baseline Hgb (g/dL)) × 0.24 + 500 mg.14 Our target Hgb will be 11.0 g/dL. The determination of the treatment duration and dosage will be based on the calculation of the iron deficit.

    Treatment: Venofer 200 MG Per 10 ML Injection

  • Oral ironPlacebo, for comparison

    Ferrous sulfate 325 mg orally every other day on an empty stomach with lemon/orange water until delivery.

    Treatment: Ferrous sulfate

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Early Intravenous Versus Oral Iron for Ferritin-Defined Iron Deficiency in Pregnancy: A Prospective Comparative Study
Record updated
9 November 2026