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

• Status: Unknown status
• Trial end date: 2018-10-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abdelwahed, Mai Mahmoud Mohamed, M.D.
• Treatments: Lactoferrin

Criteria

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 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, cardiovascular abnormalities.

• 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.