Comparison Of Efficacy Of Iron Polymaltose Complex And Ferrous Sulphate In Iron Deficiency Anemia In Pediatric Patients With Iron Deficiency Anemia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 198
- 试验地点
- 1
- 主要终点
- Increase Of Hemoglobin Level
研究概览
简要总结
This study aims to compare the efficacy of two iron preparation for the management of children presented with iron deficiency anemia. Ferrous sulphate and lron polymaltose (ferric form) are most commonly used preparations. Both drugs are easily available in market and are often recommended by pediatriclans. The efficacy, bioavail.tbilily, side effects and cost of these preparations vary. This study is designed to find out a drug with better efficacy that can be used for treatment of iron deficiency anemia in local population.
详细描述
Anemia remains a condition with high prevalence in populations worldwide. It is predominantly associated with nutritional status and socioeconomic conditions or hereditary diseases. The majority of anemia cases are linked to iron deficiency-named iron-deficiency anemia resulting from low intake of iron-rich foods in the diet, or from substantial blood loss.
This study aims to compare the efficacy of two iron preparation for the management of children presented with iron deficiency anemia. Ferrous sulphate and lron polymaltose (ferric form) are most commonly used preparations. Both drugs are easily available in market and are often recommended by pediatriclans. The efficacy, bioavail.tbilily, side effects and cost of these preparations vary. This study is designed to find out a drug with better efficacy that can be used for treatment of iron deficiency anemia in local population.
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 (Participant)
盲法说明
Patients will be divided randomly in two groups using blocked randomization generated by computer software.
入排标准
- 年龄范围
- 6 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients having iron deficiency anemia
排除标准
- •Patients diagnosed as congenital aplastic anemia or thalassemia (Determined from medical record).
- •Patients who were transfused in previous 4 weeks (will be determined on history)
- •Children having mal-absorption syndrome and diarrheal illnesses. (will be determined on history and medical record)
- •Gastrointestinal bleeding suggested by history of hematemesis (bloody vomit), melena (black colored stools) or bloody stools.
研究组 & 干预措施
Group A (Ferrous sulphate)
Group A will be given Ferrous sulphate in a dose of 6mg/kg/day of elemental iron once daily for 8 weeks orally in syrup form.
干预措施: Ferrous sulfate (Drug)
Group B (Iron Polymaltose complex)
Group B will be given Iron Polymaltose complex in a dose of 6mg/kg/day of elemental iron once daily orally for 8 weeks.
干预措施: Iron Polymaltose Complex (Drug)
结局指标
主要结局
Increase Of Hemoglobin Level
时间窗: 8 weeks
Increase in Hemoglobin level measured by a Complete Blood Count as compared to pre treatment Hemoglobin
次要结局
未报告次要终点
研究者
Arooj Khan
Post Graduate Resident, Department of Child Health
Khyber Teaching Hospital