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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
361
325 mg tablets (65 mg elemental iron) with instructions to take 1 tablet by mouth (PO) TID with 8 ounces of tap water, 1 hour before meals from Day 0 until Day 42
A maximum of 1,000 mg iron as IV VIT-45 given at weekly intervals until the the cumulative dose has been reached or a maximum of 2,500 mg has been administered
Luitpold Pharmaceuticals
Norristown, Pennsylvania, United States
Number of Subjects Who Achieved 'Success' Meaning a ≥ 2.0 Increase in Hemoglobin
Time frame: anytime between baseline and the end of study or time to intervention
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