Comparison of the Safety and Efficacy of Intravenous Iron Versus Oral Iron in Subjects Who Display Postpartum Anemia

Comparison of the Safety and Efficacy of Intravenous Iron vs Oral Iron in Subjects Who Display Postpartum Anemia

This study compares the safety and efficacy of intravenous iron vs oral iron in subjects who display postpartum anemia.

This is an open label, Phase III, randomized, active controlled study of intravenous iron vs oral iron in anemic post partum patients.

Inclusion Criteria:

• Female Subjects able to give consent
• Post partum patients
• Baseline Hbg< /= 10
• Agree to practice birth control
• Demonstrate willingness to comply with protocol restrictions

Exclusion Criteria:

• Known hypersensitivity reaction to oral or IV iron (VIT-45)
• Documented history of discontinuing oral iron
• Significant bleeding
• History of anemia other that iron deficiency anemia
• Severe Psychiatric disorders
• Active severe infection
• Known Hepatitis B antigen or Hep C viral antibody or active hepatitis
• Known HIV antibody
• Received investigational product within 30 days
• Alcohol abuse
• Hemochromatosis or other iron storage disorder