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

NCT03009578 — Phase 3, Completed, 100 participants, Assiut University

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

Registry	NCT03009578
Status	Completed
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	100 (Actual)
Sponsor	Assiut University (Other)
Conditions	Anemia
Interventions	Iron Sucrose Injection, Ferrous Bisglycinate (Drug)
Dates	start 2017-02-01, primary completion 2018-04-30, completion 2018-06-05, first posted 2017-01-04, last updated 2018-07-03
Locations	1 site in Egypt

-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

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+Arms and interventions

Arm	Type	Interventions	Description
Intravenous iron	Experimental	Drug: 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	Active comparator	Drug: Ferrous Bisglycinate	Women will receive oral ferrous bis-glycinate fully reacted amino acid 27 mg tablets

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

+Outcome measures

Primary outcomes

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

Secondary outcomes

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

+Eligibility

Sex: Female, ages: 18 Years to 35 Years

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.

+Locations (1)

Facility	City	Country	Status
Assiut Faculty of Medicine	Asyut	Egypt

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