Bovine Lactoferrin Versus Ferrous Sulphate In The Treatment Of Iron Deficiency Anemia During Pregnancy

Phase

Condition

Anemia

Treatment

N/A

Clinical Study ID

NCT03202615

AbdelwahedM

IbrahimK

AshoushS

ElhawariG

Ages 20-30
Female

Study Summary

130 pregnant women with Iron deficiency anemia, in the 2nd trimester (microcytic hypochromic anemia, hemoglobin range from 9-10.5g/dl, serum ferritin less than 12 ng/ml), from the outpatient clinics in the Obstetrics and Gynecology Department, in Ain Shams University Hospital, Cairo, Egypt, will be enrolled and distributed into one of 2 groups by a computer generated random number table. Each of the 2 groups will receive 2 medication for 2 months with specific instruction to increase iron absorption. One group named L will receive powders of bovine lactoferrin and tablets of placebo form, the 2nd named F will receive ferrous sulphate tablet and placebo in powder form. Hemoglobin concentration, packed-cell volume (PCV) , mean cell volume (MCV), mean corpuscular hemoglobin (MCH), mean cell hemoglobin concentration (MCHC), Serum ferritin will be done at the start and the end of the treatment period.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Pregnant with singleton intrauterine pregnancy
14- 20 weeks of gestation
Have iron deficiency anemia (IDA) with hemoglobin 9 to less than 10.5 g/dl.

Exclusion

Exclusion Criteria:

Patients with a history of anemia due to any other causes such as chronic blood loss,hemolytic anemia, and thalassemia (including thalassemic trait).
Hemoglobin less than 9 g/dL.
Clinical and/or laboratory evidence of hepatic, renal, hematologic, cardiovascularabnormalities.
History of acid-peptic disorders, esophagitis, or hiatal hernia.
Family history of thalassemia, sickle cell anemia, or malabsorption syndrome.
Medical disorders with pregnancy.
Bleeding in early pregnancy.
Allergies to milk proteins / hypersensitivity to iron preparations.
History of ingestion of any hematinics within the last 1 month before study entry.
Recent blood transfusion.
Refusal to participate in the study.

Study Design

September 01, 2015

October 31, 2018

Study Description

The study will includes130 pregnant women, from the outpatient clinics in the Obstetrics and Gynecology Department, in Ain Shams University Hospital, Cairo, Egypt. Women should be diagnosed as having iron deficiency anemia, in the 2nd trimester (complete blood count, showing microcytic hypochromic anemia, hemoglobin range from 9-10.5, serum ferritin less than 12 ng/ml). Women will be enrolled and distributed into one of 2 groups by a computer generated random number table. Each of the 2 groups will receive 2 medication for 2 months with specific instruction to increase iron absorption. One group named L will receive powders of bovine lactoferrin and tablets of placebo form, the 2nd named F will receive ferrous sulphate tablet and placebo in powder form. Hemoglobin concentration, PCV, MCV, MCH, MCHC, Serum ferritin will be done at the start and the end of the treatment period.

Connect with a study center

Mai Mahmoud Mohamed
Alexandria, 12345
Egypt
Active - Recruiting

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