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

Anemia Clinical Trial

Official title:

Intravenous Iron Sucrose Versus Oral Ferrous Bis-glycinate for Treatment of Postpartum Iron Deficiency Anemia: a Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03009578
• Other study ID #: OFB-IDA
• Status: Completed
• Phase: Phase 3
• Start date: February 1, 2017
• Est. completion date: June 5, 2018

Study information

• Verified date: June 2018
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 5, 2018
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency

Intervention

Drug:
• Iron Sucrose Injection
iron Intramuscular injections
• Ferrous Bisglycinate
oral iron tablets

Locations

Country	Name	City	State
Egypt	Assiut Faculty of Medicine	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the percentage of patients achieving Hb rise 3 gm or more		6 weeks
Secondary	Mean rise of Hb from baseline to 6 weeks.		6 weeks