Lactoferrin With Ferrous Gluconate Versus Ferrous Gluconate in Treatment of Iron Deficiency Anemia During Pregnancy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- • Hemoglobin (Hb) level
研究概览
简要总结
Study Procedures:
All patients will undergo the following:
Informed consent will be obtained from all the participants in this study before enrolling in this study and all participants will be subjected to a detailed clinical assessment including: a detailed history, general, abdominal examinations, Investigations.
- History taking:
- Personal history: name, age, occupation and address.
- Menstrual and obstetric history: Date of LMP, expected date of delivery which will be calculated according to Naegle's rule and gestational age. In addition to history of presence of any menstrual irregularities, duration.
- Past History: of Anemia in previous pregnancy, other diseases like Thalassemia, sickle cell anemia, liver or renal diseases or any other condition that may affect hemoglobin.
- Medical examination:
- General: Assessment of complexion and vital data (blood pressure, pulse, capillary refill)
- Abdominal examination to assess fundal height.
- Investigations to perform will include:
Laboratory: Complete blood count (microcytic hypochromic anemia) Imaging: Ultrasound to assess biometry to exclude fetal growth restriction. Women will be divided in two groups with 20 in each group, the first group will receive one tab of ferrous gluconate 300mg administered orally twice per day for 4 weeks and the second group will receive lactoferrin sachets 100mg with ferrous gluconate 300mg twice per day for 4 weeks Patients were assigned to take the medication orally; once daily before breakfast, and Pravotin (100 sachets were be dissolved each in ¼ glass of water and taken before breakfast). Patients were advised to avoid the intake of tea, coffee, milk, milk products, antacids and calcium preparation within 2 hours before or after iron capsules.
Women will be told to record side effects as nausea, vomiting, abdominal discomfort and constipation.
Women will have a blood sample (CBC) withdrawn after 2 to 4 weeks to assess rise in pregnant anemia.
详细描述
This study included two groups:
Group I: 20 patients were given ferrous gluconate 300 mg (Ferrous-Gluconate®, tab.300mg glucofer, Egypt) two times daily.
Group II: 20 patients were given lactoferrin 100mg (Pravotin-sachets®,100mg, Hygint, Egypt) with ferrous gluconate twice daily.
hematological parameters (rise in hemoglobin) and the adverse effects of both drugs were studied at registration and after 4 weeks
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
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Associated chronic medical disorder (CKD, liver disease, peptic ulcer and chronic blood loss).
- •Associated bleeding disorder
- •Anaemia requiring blood tranfusion (Hb < 7gm/dL)
- •Hypersensitivity to iron preparations
- •Haemoglobinopathies (G6PD, thalassemias, sickle cell disease)
研究组 & 干预措施
group I
the first group 20 patients will receive one tab of ferrous gluconate 300mg administered orally twice per day for 4 weeks (Ferrous-Gluconate®, tab.300mg glucofer, Egypt) two times daily.
干预措施: Ferrous Gluconate 300 MG (Drug)
group II
20 patients were given lactoferrin 100mg (Pravotin-sachets®,100mg, Hygint, Egypt) with ferrous gluconate twice daily for 4 weeks Patients were assigned to take the medication orally; once daily before breakfast, and Pravotin (100 sachets were be dissolved each in ¼ glass of water and taken before breakfast). Patients were advised to avoid the intake of tea, coffee, milk, milk products, antacids and calcium preparation within 2 hours before or after iron capsules.
干预措施: ferrous gluconate with lactoferrin (Drug)
结局指标
主要结局
• Hemoglobin (Hb) level
时间窗: 4 weeks
hemoglobin will be measured before and after treatment by 4 weeks (HB in gm/dl)
serum ferritin
时间窗: 4 weeks
serum ferritin will be measured before and after treatment by 4 weeks (ferritin in ug/l )
次要结局
- gastrointestinal side effects(4 weeks)