Comparison of Twice Weekly Versus Daily Iron Therapy in Treating Anemia in Children With Cerebral Palsy
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 160
- 主要终点
- Change in Hemoglobin levels from baseline
研究概览
简要总结
a randomized clinical trial to compare the effect of twice weekly versus daily iron therapy in treating anemia in children with cerebral palsy, to be conducted at Department of pediatric medicine children's hospital PIMS islamabad.
详细描述
a total of 160 children of either gender with age between 6 and 60 months diagnosed with cerebral palsy and concomitant iron deficiency anemia will be enrolled, they will be allocated two groups by lottery method. one group will be given ferrous sulphate 3mg/kg daily in the form of syrup and other group will be given ferrous sulphate 3mg/kg twice weekly in the form of syrup for a period of 4 weeks. the primary outcome will be measured as rise in hemoglobin levels more than or equal to 1g/dl at 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
- Single (Outcomes Assessor)
盲法说明
laboratory personnel only will be blind
入排标准
- 年龄范围
- 6 Months 至 60 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All the children with cerebral palsy who are diagnosed cases of iron deficiency anaemia
- •Age 06 months to 5 years
- •Both genders
排除标准
- •>5 years of age
- •Children with severe anaemia requiring transfusion (Hb<5 g/L)
- •Children with history of taking oral/IV iron supplements or repeated blood transfusions during last one month
- •Children with concomitant diarrheal disease
- •Where parents are not willing to participate in the study
研究组 & 干预措施
Daily Group
one group will receive ferrous sulphate 3mg/kg in the form of syrup daily
干预措施: Ferrous Sulfate Oral Product (Drug)
Twice Weekly Group
other group will receive ferrous sulphate 3mg/kg in the form of syrup twice weekly.
干预措施: Ferrous Sulfate Oral Product (Drug)
结局指标
主要结局
Change in Hemoglobin levels from baseline
时间窗: 4 weeks
rise in Hb at the end of 4 weeks as more than equal to 1g/dl
次要结局
- Mean change in MCV (Mean Corpuscular Volume)(4 weeks)
- Mean change in mean corpuscular hemoglobin concentration (MCHC)(4 weeks)
研究者
Dr Yusra Kafait
Pediatrics Resident
Shaheed Zulfiqar Ali Bhutto Medical University