Efficacy and safety of oral liposomal iron in children with functional iron deficiency anemia and chronic kidney disease
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- To determine the increase in hemoglobin levels in children aged 3 to 18 years with chronic kidney disease not on dialysis with anemia due to functional iron deficiency - transferrin saturation less than 20 percentage and serum ferritin more than 100 to 200 microgram per l who are supplemented with oral liposomal iron at a dose of 29 mg/day for children weighing less than 25 kg and 58 mg per day for more than or equal to 25 kg weight for a duration of 12 weeks
研究概览
简要总结
| All |
| children with CKD stage 2 to 5, not on dialysis with anemia will be screened for |
| functional iron deficiency, as defined by KDIGO. Patients meeting all |
| inclusion and none of exclusion criteria will be approached for consent. If |
| consent is provided, demographic and baseline clinical details will be noted. |
All eligible patients will undergo baseline blood investigations including serum iron, serum ferritin, TIBC, Ret He, HRC. Patient will be provided sachets of liposomal iron with 29 mg elemental iron per sachet and as per the body weight (29 mg if less than 25 kg then 29 mg and 58 mg if more than or equal to 25 kg), patients will be advised to take these sachets empty stomach every day for 12 weeks. Repeat blood investigations will be done at 4, 8, and 12 weeks. All statistical analysis will be carried out at a 5% level of significance and the p value less than 0.05 will be considered as significant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 3.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Children with CKD stages 2 to 5 Patients in the age group of 3 years to 18 years Anemia as defined by WHO criteria Functional iron deficiency as defined by KDIGO Not receiving dialysis Erythropoiesis stimulating agent naïve or on stable dose of ESA.
排除标准
- •Known hemoglobinopathies Baseline hemoglobin than 7 g per dl Known malabsorption disorders Active infection Kidney allograft recipients Patients who received packed red cell transfusion or intravenous iron supplementation in last 4 weeks Patients with parathormone levels more than 700 pg per ml Refusal of consent.
结局指标
主要结局
To determine the increase in hemoglobin levels in children aged 3 to 18 years with chronic kidney disease not on dialysis with anemia due to functional iron deficiency - transferrin saturation less than 20 percentage and serum ferritin more than 100 to 200 microgram per l who are supplemented with oral liposomal iron at a dose of 29 mg/day for children weighing less than 25 kg and 58 mg per day for more than or equal to 25 kg weight for a duration of 12 weeks
时间窗: 12 weeks
Primary Objective
时间窗: 12 weeks
次要结局
- Efficacy parameters(Increase in transferrin saturation from baseline)
- Safety(Proportion of children with adverse events, including)
研究者
Vishnu Dev P M
ALL INDIA INSTITUTE OF MEDICAL SCIENCES , NEW DELHI