Amino Acid Chelated Iron Versus Ferrous Fumarate in the Treatment of Iron Deficiency Anemia With Pregnancy: Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Hemoglobine (Hb) Rise
研究概览
简要总结
Anemia is the commonest hematological disorder that occurs in pregnancy. According to the recent standard laid down by 'WHO', anemia is present when the Hemoglobin (Hb) concentration in the peripheral blood is 11 gm/dl or less. The most common cause of anemia in pregnancy is lack of iron. This study is done to compare the efficacy and tolerability of iron amino acid chelate and that of iron salts (ferrous fumarat).
详细描述
Anemia is the commonest hematological disorder that occurs in pregnancy. According to the recent standard laid down by 'WHO', anemia is present when the Hemoglobin (Hb) concentration in the peripheral blood is 11 gm/dl or less. The most common cause of anemia in pregnancy is lack of iron. This study is done to compare the efficacy and tolerability of iron amino acid chelate and that of iron salts (ferrous fumarat).
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women at 14 -18 weeks of gestation calculated from the first day of their last menstrual period and confirmed or modified by ultrasound
- •Hemoglobin level 8-10.5 g/dL
- •Serum ferritin<15µg/L
排除标准
- •The presence of anemia from causes other than iron deficiency(e.g: Folat deficiency anemia,Vitamin B12 deficiency, ect...).
- •Multiple gestations
- •The presence of clinical and/or laboratory evidence of hepatic, renal, hematological or cardiovascular disease
- •Patients with known gastritis
- •History of mal-absorption syndrome
- •Those with known hypersensitivity to iron preparations
- •Those under current iron supplementation
研究组 & 干预措施
Amino Acid chelated iron tab 15 mg group
Contain 75 pregnant women will recommended to take ferrotrone(iron chelated amino acid containing 15mg elemental iron) prepared by egyptian pharmaceutical company (nerhadou) once daily (a dose recommended by the company of the product).
干预措施: Amino Acid chelated iron tab 15 mg (Drug)
Ferrous Fumarate tab 350 mg( 115 mg elemental iron) group
Contain 75 pregnant women will recommended to take ferrous fumarate e.g. Hema-caps (ferrous fumarate 350 mg with elemental iron 115mg) prepared by another egyptian pharmaceutical company (Amoun pharmaceutical company) once daily but in sever cases of iron deficiency anemia (Hb<9g/dl) this dose can be doubled as recommended by the company of the product.
干预措施: Ferrous Fumarate tab 350 mg( 115 mg elemental iron) (Drug)
结局指标
主要结局
Hemoglobine (Hb) Rise
时间窗: after 12 weeks of treatment.
follow up CBC after 12 weeks of treatment given
次要结局
- Adverse effects of the medication given(3months)
- Hemoglobine (Hb) Rise(after 4,8 weeks of treatment.)
研究者
Ahmed Abdel Shafy El Shahawy
lecturer
Ain Shams University