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

NCT03009578 | Completed Phase 3 DMC

• 1 other identifier: OFB-IDA
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Anemia

Outcome Measures

Primary Outcomes (1)

• the percentage of patients achieving Hb rise 3 gm or more

  6 weeks

Secondary Outcomes (1)

• Mean rise of Hb from baseline to 6 weeks.

  6 weeks

Study Arms (2)

Intravenous iron

EXPERIMENTAL

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

Oral ferrous bis-glycinate

ACTIVE COMPARATOR

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

Drug: Ferrous Bisglycinate

Interventions

Iron Sucrose Injection DRUG

iron Intramuscular injections

Intravenous iron

Ferrous Bisglycinate DRUG

oral iron tablets

Oral ferrous bis-glycinate

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Severe anemia \< 7 gm/dl.
• Women received iron therapy during pregnancy.
• Intolerance to iron preparations
• Anemia due to other causes
• Peripartum blood transfusion.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut Faculty of Medicine

Asyut, Egypt

Location

MeSH Terms

Conditions

Anemia

Interventions

Ferric Oxide, Saccharated; ferrous bisglycinate

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Glucaric Acid; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: January 2, 2017
• First Posted: January 4, 2017
• Study Start: February 1, 2017
• Primary Completion: April 30, 2018
• Study Completion: June 5, 2018
• Last Updated: July 3, 2018

Record last verified: 2018-06

Locations

EG (1)