Bovine Lactoferrin Versus Ferrous Sulphate In The Treatment Of Iron Deficiency Anemia During Pregnancy: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- change in Hemoglobin concentration
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 30 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: L (lactoferrin) (Dietary Supplement)
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.
干预措施: F (ferrous sulphate) (Drug)
结局指标
主要结局
change in Hemoglobin concentration
时间窗: At time 0 (enrollment),1 and 2 months
grams/dL
次要结局
- 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)
- 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)
- Side effects:(At time 0 (enrollment) and every 2 weeks, for 2 months)