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

Anemia During Pregnancy Clinical Trial

Official title:

Bovine Lactoferrin Versus Ferrous Sulphate In The Treatment Of Iron Deficiency Anemia During Pregnancy: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03202615
• Other study ID #: AbdelwahedM
• Secondary ID: AshoushSIbrahimK
• Status: Recruiting
• Phase: Phase 4
• Start date: September 2015
• Est. completion date: October 2018

Study information

• Verified date: July 2018
• Source: Abdelwahed, Mai Mahmoud Mohamed, M.D.
• Contact: Mai M Abdelwahed, specialist
• Phone: 01152684127
• Email: maya_mohamed0[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: October 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anemia
• Anemia During Pregnancy
• Anemia, Iron-Deficiency

Intervention

Dietary Supplement:
• L (lactoferrin)
Dietary Supplement: Pravotin sachets (Hygint, Egypt) containing bLf One sachet of Pravotin contains 100 mg of bLf. Dosage: one sachet twice a day before meals with placebo tablets

Drug:
• F (ferrous sulphate)
Drug: FerroGrad by Abbott Dosage: one capsule three times /day containing150 mg of dried ferrous sulfate capsules (Ferrofol capsules, Eipico, Egypt), with placebo sachets.

Locations

Country	Name	City	State
Egypt	Mai Mahmoud Mohamed	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Abdelwahed, Mai Mahmoud Mohamed, M.D.

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in Hemoglobin concentration	grams/dL	At time 0 (enrollment),1 and 2 months
Secondary	Serum ferritin	nanograms per milliliter	At time 0 (enrollment) and 2 months
Secondary	mean cell volume (MCV)	fL/red cell in adult	At time 0 (enrollment) and 2 months
Secondary	mean corpuscular hemoglobin (MCH)	picograms (pg)/cell in adults	At time 0 (enrollment) and 2 months
Secondary	mean cell hemoglobin concentration (MCHC)	g/dL	At time 0 (enrollment) and 2 months
Secondary	cost	The average drug cost by LE.	1-2 months
Secondary	percentage of women who agree to take each of the two drugs for a future whole pregnancy.	percentage	At time 0 (enrollment) and every 2 weeks, for 2 months
Secondary	Side effects:	scaling score of side effects of oral administration of bLf and ferrous sulfate as: gastrointestinal discomfort; nausea; heart burn; constipation The degree of side effects will be assessed using objective scaling scoring system: 0 (no symptoms), 1 (mild not requiring any change in life style), 2 (severe controlled with another method), 3 (severe not controlled but accepting), 4 (severe not controlled and not accepting).	At time 0 (enrollment) and every 2 weeks, for 2 months