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

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ClinicalTrials.gov Identifier: NCT03202615
Recruitment Status : Recruiting
First Posted : June 28, 2017
Last Update Posted : July 9, 2018
Sponsor:
Information provided by (Responsible Party):
Abdelwahed, Mai Mahmoud Mohamed, M.D.

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.

Condition or disease Intervention/treatment Phase
Anemia During Pregnancy Dietary Supplement: L (lactoferrin) Drug: F (ferrous sulphate) Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Bovine Lactoferrin Versus Ferrous Sulphate In The Treatment Of Iron Deficiency Anemia During Pregnancy: A Randomized Controlled Trial
Study Start Date : September 2015
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron

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 Name: 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 Name: Ferrofol capsules




Primary Outcome Measures :
  1. change in Hemoglobin concentration [ Time Frame: At time 0 (enrollment),1 and 2 months ]
    grams/dL


Secondary Outcome Measures :
  1. Serum ferritin [ Time Frame: At time 0 (enrollment) and 2 months ]
    nanograms per milliliter

  2. mean cell volume (MCV) [ Time Frame: At time 0 (enrollment) and 2 months ]
    fL/red cell in adult

  3. mean corpuscular hemoglobin (MCH) [ Time Frame: At time 0 (enrollment) and 2 months ]
    picograms (pg)/cell in adults

  4. mean cell hemoglobin concentration (MCHC) [ Time Frame: At time 0 (enrollment) and 2 months ]
    g/dL

  5. cost [ Time Frame: 1-2 months ]
    The average drug cost by LE.

  6. percentage of women who agree to take each of the two drugs for a future whole pregnancy. [ Time Frame: At time 0 (enrollment) and every 2 weeks, for 2 months ]
    percentage

  7. Side effects: [ Time Frame: At time 0 (enrollment) and every 2 weeks, for 2 months ]

    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).



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Ages Eligible for Study:   20 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03202615


Contacts
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Contact: Mai M Abdelwahed, specialist 01152684127 ext 002 maya_mohamed0@hotmail.com
Contact: Gihan E El Hawwary, specialist 01210333986 ext 002

Locations
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Egypt
Mai Mahmoud Mohamed Recruiting
Alexandria, Egypt, 12345
Contact: Mai Ms Abdelwahed, Master    01152684127 ext 002    maya_mohamed0@hotmail.com   
Contact: Sherif Mr Ashoush, Doctoral    01222660266 ext 002    sherifashoush@hotmail.com   
Sponsors and Collaborators
Abdelwahed, Mai Mahmoud Mohamed, M.D.
Investigators
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Study Chair: Sherif A Ashoush, a. professor personal

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Responsible Party: Abdelwahed, Mai Mahmoud Mohamed, M.D.
ClinicalTrials.gov Identifier: NCT03202615     History of Changes
Other Study ID Numbers: AbdelwahedM
AshoushS ( Other Identifier: personal )
IbrahimK ( Other Identifier: personal )
ElhawariG ( Other Identifier: personal )
First Posted: June 28, 2017    Key Record Dates
Last Update Posted: July 9, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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

Keywords provided by Abdelwahed, Mai Mahmoud Mohamed, M.D.:
lactoferrin
iron deficiency anemia in pregnancy

Additional relevant MeSH terms:
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Anemia
Anemia, Iron-Deficiency
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Lactoferrin
Anti-Infective Agents