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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Anemia During Pregnancy

Intervention / Treatment
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* Dietary Supplement: L (lactoferrin)
* Drug: F (ferrous sulphate)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: L (lactoferrin in IDA with pregnancy)<br>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)<br>* 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<br>* Other names: Pravotin sachets;|
| Active Comparator: F (ferrous sulphate with pregnancy)<br>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)<br>* Drug: FerroGrad by Abbott Dosage: one capsule three times /day containing150 mg of dried ferrous sulfate capsules (Ferrofol capsules, Eipico, Egypt), with placebo sachets.<br>* Other names: Ferrofol capsules;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lactoferrin, iron deficiency anemia in pregnancy