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

NCT03202615 | Unknown Phase 4 DMC FDA Drug

• 4 other identifiers: AbdelwahedMAshoushSIbrahimKElhawariG
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Anemia During Pregnancy

Keywords

lactoferrin; iron deficiency anemia in pregnancy

Outcome Measures

Primary Outcomes (1)

• change in Hemoglobin concentration

  grams/dL

  At time 0 (enrollment),1 and 2 months

Secondary Outcomes (7)

• Serum ferritin

  At time 0 (enrollment) and 2 months

• mean cell volume (MCV)

  At time 0 (enrollment) and 2 months

• mean corpuscular hemoglobin (MCH)

  At time 0 (enrollment) and 2 months

• mean cell hemoglobin concentration (MCHC)

  At time 0 (enrollment) and 2 months

• cost

  1-2 months

Study Arms (2)

L (lactoferrin in IDA with pregnancy)

EXPERIMENTAL

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)

F (ferrous sulphate with pregnancy)

ACTIVE COMPARATOR

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)

Interventions

L (lactoferrin) 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

Also known as: Pravotin sachets

L (lactoferrin in IDA with pregnancy)

F (ferrous sulphate) 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.

Also known as: Ferrofol capsules

F (ferrous sulphate with pregnancy)

Eligibility Criteria

• Age: 20 Years - 30 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abdelwahed, Mai Mahmoud Mohamed, M.D.: lead

Study Sites (1)

Mai Mahmoud Mohamed

Alexandria, 12345, Egypt

RECRUITING

MeSH Terms

Interventions

Lactoferrin; ferrous sulfate

Intervention Hierarchy (Ancestors)

Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Glycoproteins; Glycoconjugates; Carbohydrates; Transferrins; Iron-Binding Proteins; Carrier Proteins; Proteins; Amino Acids, Peptides, and Proteins; Lactoglobulins; Whey Proteins; Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Globulins; Metalloproteins

Study Officials

• Sherif A Ashoush, a. professor

  personal

  STUDY CHAIR

Central Study Contacts

Mai M Abdelwahed, specialist

CONTACT

01152684127; maya_mohamed0@hotmail.com

Gihan E El Hawwary, specialist

CONTACT

01210333986

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2015
• First Posted: June 28, 2017
• Study Start: September 1, 2015
• Primary Completion: August 1, 2018
• Study Completion: October 1, 2018
• Last Updated: July 9, 2018

Record last verified: 2018-07

Locations

EG (1)