Bovine Lactoferrin Versus Ferrous Sulphate In The Treatment Of Iron Deficiency Anemia During Pregnancy
- Conditions
- Anemia During Pregnancy
- Interventions
- Dietary Supplement: L (lactoferrin)
- Registration Number
- NCT03202615
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 130
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description L (lactoferrin in IDA with pregnancy) L (lactoferrin) 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. F (ferrous sulphate with pregnancy) F (ferrous sulphate) 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.
- Primary Outcome Measures
Name Time Method change in Hemoglobin concentration At time 0 (enrollment),1 and 2 months grams/dL
- Secondary Outcome Measures
Name Time Method Serum ferritin At time 0 (enrollment) and 2 months nanograms per milliliter
mean cell volume (MCV) At time 0 (enrollment) and 2 months fL/red cell in adult
mean corpuscular hemoglobin (MCH) At time 0 (enrollment) and 2 months picograms (pg)/cell in adults
mean cell hemoglobin concentration (MCHC) At time 0 (enrollment) and 2 months g/dL
cost 1-2 months The average drug cost by LE.
percentage of women who agree to take each of the two drugs for a future whole pregnancy. At time 0 (enrollment) and every 2 weeks, for 2 months percentage
Side effects: 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).
Trial Locations
- Locations (1)
Mai Mahmoud Mohamed
🇪🇬Alexandria, Egypt