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

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

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

Study Overview

• Status: Completed
• Conditions: Anemia
• Intervention / Treatment: Drug: Iron Sucrose Injection; Drug: Ferrous Bisglycinate

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt
    • Assiut Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intravenous iron; 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	Drug: Iron Sucrose Injection; iron Intramuscular injections
Active Comparator: Oral ferrous bis-glycinate; Women will receive oral ferrous bis-glycinate fully reacted amino acid 27 mg tablets	Drug: Ferrous Bisglycinate; oral iron tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
the percentage of patients achieving Hb rise 3 gm or more	6 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Mean rise of Hb from baseline to 6 weeks.	6 weeks

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Actual): April 30, 2018
• Study Completion (Actual): June 5, 2018

Study Registration Dates

• First Submitted: January 2, 2017
• First Submitted That Met QC Criteria: January 3, 2017
• First Posted (Estimate): January 4, 2017

Study Record Updates

• Last Update Posted (Actual): July 3, 2018
• Last Update Submitted That Met QC Criteria: June 30, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Anemia, Hypochromic; Iron Metabolism Disorders; Anemia, Iron-Deficiency; Anemia; Hematinics; Ferric Oxide, Saccharated
• Other Study ID Numbers: OFB-IDA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No