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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
130
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
Drug: FerroGrad by Abbott Dosage: one capsule three times /day containing150 mg of dried ferrous sulfate capsules (Ferrofol capsules, Eipico, Egypt), with placebo sachets.
Mai Mahmoud Mohamed
Alexandria, Egypt
RECRUITINGchange in Hemoglobin concentration
grams/dL
Time frame: At time 0 (enrollment),1 and 2 months
Serum ferritin
nanograms per milliliter
Time frame: At time 0 (enrollment) and 2 months
mean cell volume (MCV)
fL/red cell in adult
Time frame: At time 0 (enrollment) and 2 months
mean corpuscular hemoglobin (MCH)
picograms (pg)/cell in adults
Time frame: At time 0 (enrollment) and 2 months
mean cell hemoglobin concentration (MCHC)
g/dL
Time frame: At time 0 (enrollment) and 2 months
cost
The average drug cost by LE.
Time frame: 1-2 months
percentage of women who agree to take each of the two drugs for a future whole pregnancy.
percentage
Time frame: 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).
Time frame: At time 0 (enrollment) and every 2 weeks, for 2 months
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