Daily versus alternate day dosing of iron therapy for anemia in CKD stage 2-4 in children of age group 2-18 years: An open labelled randomised control trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- AIIMS Bhopal
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To compare increase in transferrin saturation in alternate day iron therapy(6 mg/kg/dose) versus daily oral iron therapy (3 mg/kg/day) in children aged 2-18 years with CKD stage 2-4 over a 12 week period.
研究概览
简要总结
At first contact with children who fit the inclusion criteria, which include children aged 2 year to 18 years with iron deficiency anemia in CKD defined asper KDIGO 2025 guideline will be screened for the study.After enrollment eligible participants will be randomized in OD: 3 mg/kg/day (control group) or alternate day therapy 6 mg/kg/dose(intervention group) which is given for 3 months. All measurements such as hemoglobin, iron profile studies including transferrin saturation, ferritin, TIBC,and serum iron along with hepcidin and IL6 levels. These are done at baseline and at the end of 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 2.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Children with a diagnosis of anemia in CKD stage G2–4 with Ferritin less than 100 with transferrin saturation less than 40% or if ferritin is between 100-300 and transferrin saturation less than 25%.
- •Hemoglobin of less than 11.5g/dl(5-11 years), less than 12 g/dl(12-14 years), for girls of more than 15 years, hemoglobin less than 12 g/dl and for boys more than 15 years, haemoglobin of less than 13 g/dl.
排除标准
- •Current use or use within last 3 months of oral or intravenous iron preparations 2) Associated B12/folate deficiency 3) Blood transfusion within last 3 months 3) Associated hemolytic anemia- Sickle cell, thalassemia 4) Anemia attributed from blood loss(intestinal bleed or bleeding from any other sites).
结局指标
主要结局
To compare increase in transferrin saturation in alternate day iron therapy(6 mg/kg/dose) versus daily oral iron therapy (3 mg/kg/day) in children aged 2-18 years with CKD stage 2-4 over a 12 week period.
时间窗: 3 months
次要结局
- To compare the change in hemoglobin between the two groups over the study period(3 months)
- To assess the incidence and severity of adverse events gastrointestinal side effects (nausea, vomiting, abdominal pain, constipation) between each group.(3 months)
- To compare adherence between 2 groups(3 months)
- To compare hepcidin and IL6 level at onset and at 12 weeks between 2 groups(3 months)
- To correlate between baseline Hb, RBC indices, ferritin, stage of CKD and PTH to response to oral iron therapy(3 months)