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

NCT ID: NCT03202615

Last Updated: 2018-07-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2018-10-31

Brief 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.

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.

Conditions

Anemia During Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

L (lactoferrin)

Intervention Type: DIETARY_SUPPLEMENT

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

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.

Group Type: ACTIVE_COMPARATOR

F (ferrous sulphate)

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

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.

Intervention Type: DRUG

Other Intervention Names

Pravotin sachets; Ferrofol capsules

Eligibility 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Abdelwahed, Mai Mahmoud Mohamed, M.D.

INDIV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sherif A Ashoush, a. professor

Role: STUDY_CHAIR

personal

Locations

Mai Mahmoud Mohamed

Alexandria, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Mai M Abdelwahed, specialist

Role: CONTACT

maya_mohamed0@hotmail.com

01152684127 ext. 002

Gihan E El Hawwary, specialist

Role: CONTACT

01210333986 ext. 002

Facility Contacts

Mai Ms Abdelwahed, Master

Role: primary

maya_mohamed0@hotmail.com

01152684127 ext. 002

Sherif Mr Ashoush, Doctoral

Role: backup

sherifashoush@hotmail.com

01222660266 ext. 002

Other Identifiers

AshoushS

Identifier Type: OTHER

Identifier Source: secondary_id

IbrahimK

Identifier Type: OTHER

Identifier Source: secondary_id

ElhawariG

Identifier Type: OTHER

Identifier Source: secondary_id

AbdelwahedM

Identifier Type: -

Identifier Source: org_study_id