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

• Sponsor: Assiut University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03009578
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Actual Duration (Months): 16.1
• Patients Per Site Per Month: 6.2

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Anemia	Drug: Iron Sucrose Injection; Drug: Ferrous Bisglycinate	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Intravenous Iron Sucrose Versus Oral Ferrous Bis-glycinate for Treatment of Postpartum Iron Deficiency Anemia: a Randomized Clinical Trial
• Actual Study Start Date: Feb 1, 2017
• Actual Primary Completion Date: Apr 30, 2018
• Actual Study Completion Date: Jun 5, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. the percentage of patients achieving Hb rise 3 gm or more [6 weeks]

Secondary Outcome Measures

1. Mean rise of Hb from baseline to 6 weeks. [6 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assiut Faculty of Medicine	Assiut		Egypt

Sponsors and Collaborators

• Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ahmed Mohamed Abbas, Dr, Assiut University
• ClinicalTrials.gov Identifier: NCT03009578
• Other Study ID Numbers: OFB-IDA
• First Posted: Jan 4, 2017
• Last Update Posted: Jul 3, 2018
• Last Verified: Jun 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Anemia; Anemia, Iron-Deficiency; Ferric Oxide, Saccharated

Study Results

No Results Posted as of Jul 3, 2018