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

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

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.

Study Overview

• Status: Unknown
• Conditions: Anemia During Pregnancy
• Intervention / Treatment: Dietary supplement: L (lactoferrin); Drug: F (ferrous sulphate)

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 130
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt, 12345
    • Recruiting
    • Mai Mahmoud Mohamed
    • Contact: Mai Ms Abdelwahed, Master; Phone Number: 002 01152684127; Email: maya_mohamed0@hotmail.com
    • Contact: Sherif Mr Ashoush, Doctoral; Phone Number: 002 01222660266; Email: sherifashoush@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 30 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: L (lactoferrin in IDA with pregnancy); Pregnant women with IDA, in the 2nd trimester are enrolled and treated for 2 months regularly with oral administration of 100 mg bLf granules (Pravotin sachets , Hygint, Egypt) in 1/4 glass of water twice a day before meals in addition to placebo tablets three time per day on an empty stomach.	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; Other Names: Pravotin sachets
Active Comparator: F (ferrous sulphate with pregnancy); Pregnant women with IDA, in the 2nd trimester are enrolled and treated for 2 months regularly with oral administration of 150 mg of dried ferrous sulphate capsules (Ferrofol capsules, Eipico, Egypt), one capsule three times daily on an empty stomach, at least 1 hour before or 2 hours after meals, in addition to placebo sachets (starch) twice a day.	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.; Other Names: Ferrofol capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in Hemoglobin concentration	grams/dL	At time 0 (enrollment),1 and 2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum ferritin	nanograms per milliliter	At time 0 (enrollment) and 2 months
mean cell volume (MCV)	fL/red cell in adult	At time 0 (enrollment) and 2 months
mean corpuscular hemoglobin (MCH)	picograms (pg)/cell in adults	At time 0 (enrollment) and 2 months
mean cell hemoglobin concentration (MCHC)	g/dL	At time 0 (enrollment) and 2 months
cost	The average drug cost by LE.	1-2 months
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
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

Collaborators and Investigators

• Sponsor: Abdelwahed, Mai Mahmoud Mohamed, M.D.
• Investigators: Study Chair: Sherif A Ashoush, a. professor, personal

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Anticipated): August 1, 2018
• Study Completion (Anticipated): October 1, 2018

Study Registration Dates

• First Submitted: December 6, 2015
• First Submitted That Met QC Criteria: June 27, 2017
• First Posted (Actual): June 28, 2017

Study Record Updates

• Last Update Posted (Actual): July 9, 2018
• Last Update Submitted That Met QC Criteria: July 5, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: lactoferrin; iron deficiency anemia in pregnancy
• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Anemia, Hypochromic; Iron Metabolism Disorders; Anemia, Iron-Deficiency; Anemia; Anti-Infective Agents; Lactoferrin
• Other Study ID Numbers: AbdelwahedM; AshoushS (Other Identifier: personal); IbrahimK (Other Identifier: personal); ElhawariG (Other Identifier: personal)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes