Iron Sucrose Versus Ferrous Bis-glycinate for Treatment of Iron Deficiency Anemia

Assiut University

Status and phase: Completed; Phase 3

Conditions: Anemia

Treatments: Drug: Ferrous Bisglycinate; Drug: Iron Sucrose Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT03009578

OFB-IDA

Details and patient eligibility

About

Iron deficiency may result from inadequate dietary intake, achlorhydria or excessive ingestion of proton pump inhibitors, parasitic infestations, chronic infections and repeated pregnancies. Iron supplementation of antenatal patients is a basic tenet of antenatal care programmes in numerous developing and underdeveloped nations.

Postpartum anemia is defined as hemoglobin of less than 11.5 gm% during the postpartum period. The prevalence of postpartum anemia varies from 4 - 27%. Chronic iron deficiency due to inadequate intake/ lack of iron supplementation during pregnancy, repeated pregnancies and postpartum hemorrhage are important causes of postpartum anemia

Enrollment: 100 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Hemoglobin level 7-11.5 gm/dl. No chronic diseases. Breastfeeding. Delivered at gestational age >38 weeks. Within 24-72 hours postpartum. Women who accept to participate in the study

Exclusion criteria

1. Severe anemia < 7 gm/dl.
2. Women received iron therapy during pregnancy.
3. Intolerance to iron preparations
4. Anemia due to other causes
5. Peripartum blood transfusion.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Intravenous iron

Experimental group

Description:

Women will receive iron sucrose (sacrofer ampules 100 mg/5ml) A patient's total body iron deficit will be calculated using the Ganzoni formula (total iron dose = \[body weight (kilogram)× (15-actual Hemoglobin)\] × 2.4 + 500 mg) then the total dose will be divided on 3 settings

Treatment:

Drug: Iron Sucrose Injection

Oral ferrous bis-glycinate

Active Comparator group

Description:

Women will receive oral ferrous bis-glycinate fully reacted amino acid 27 mg tablets

Treatment:

Drug: Ferrous Bisglycinate