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

Phase 3

Completed

• Conditions: Anemia
• Interventions: Drug: Iron Sucrose Injection; Drug: Ferrous Bisglycinate

• Registration Number: NCT03009578
• Lead Sponsor: Assiut University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-01-02
• Study First Submitted QC: 2017-01-03
• Study First Posted: 2017-01-04
• Study Start: 2017-02-01
• Primary Completion: 2018-04-30
• Status Verified: 2018-06
• Study Completion: 2018-06-05
• Last Update Submitted: 2018-06-30
• Last Update Posted: 2018-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intravenous iron	Iron Sucrose Injection	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
Oral ferrous bis-glycinate	Ferrous Bisglycinate	Women will receive oral ferrous bis-glycinate fully reacted amino acid 27 mg tablets

Primary Outcome Measures

Name	Time	Method
the percentage of patients achieving Hb rise 3 gm or more	6 weeks

Secondary Outcome Measures

Name	Time	Method
Mean rise of Hb from baseline to 6 weeks.	6 weeks

Trial Locations

Locations (1)

Assiut Faculty of Medicine; 🇪🇬 Assiut, Egypt