The Effect of Vitamin D3 Supplementation on Hepcidin and Ferritin Serum Levels in Children With Chronic Kidney Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Vitamin D Level
研究概览
简要总结
The goal of this clinical trial is to analyze the effects of in vitamin D3 on serum hepcidin and ferritin levels among children with chronic kidney disease. The main questions it aims to answer is:
"What is the effect of giving vitamin D3 on serum hepcidin and ferritin levels in children with chronic kidney disease?"
We will compare the effect of vitamin D3 administration on hepcidin and ferritin between 2 groups. Group A consists of children with GFR more 90 mL/min/1,73 m2. Group B consists of children with GFR less than 90 mL/min/1,73 m2
Participants will be given the same 2000 IU of Vitamin D/day for 6 weeks.
详细描述
The primary objective of the study is to analyze the effects of vitamin D3 administration on serum levels of hepcidin and ferritin in children diagnosed with CKD. The research aims to measure these serum levels before and after vitamin D3 supplementation across different stages of kidney function, categorized by glomerular filtration rate (GFR). Specifically, it seeks to determine whether vitamin D3 can effectively reduce hepcidin levels and improve iron status as indicated by ferritin levels. The study employs a structured methodology involving children with CKD, divided into two groups based on their GFR: those with GFR < 90 mL/min/1.73 m² and those with GFR ≥ 90 mL/min/1.73 m². Serum levels of vitamin D, hepcidin, and ferritin will be measured at baseline (before supplementation) and after a defined period of vitamin D3 administration. The research will utilize statistical analyses to compare these values within and between groups to establish any significant changes attributable to the supplementation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 2 to 18 years diagnosed with chronic kidney diseases at Dr. Wahidin Sudirohusodo hospital
- •Parents have signed their child's consent to participate in the study
排除标准
- •History of blood transfusion 3 months prior
- •Liver dysfunction
- •Routine consumption of Vitamin D
- •Routine consumption of iron supplement
- •Patients diagnosed with iron deficiency anemia
研究组 & 干预措施
GFR more than 90 mL/min/1,73 m2
Children with GFR more than 90 mL/min/1,73 m2, and will be given 2000 IU of Vitamin D for 6 weeks
干预措施: Vitamin D (Drug)
GFR less than 90 mL/min/1,73 m2
Children with GFR less than 90 mL/min/1,73 m2, and will be given 2000 IU of Vitamin D for 6 weeks
干预措施: Vitamin D (Drug)
结局指标
主要结局
Vitamin D Level
时间窗: From enrollment to the end of treatment at 6 weeks
Vitamin D is measured before and after supplementation of Vitamin D
Ferritin Level
时间窗: From enrollment to the end of treatment at 6 weeks
Ferritin level before and after Vitamin D supplementation
Hepcidin level
时间窗: From enrollment to the end of treatment at 6 weeks
Hepcidin level before and after Vitamin D supplementation
次要结局
未报告次要终点
研究者
Andi Muldiana Dwi Rachmayani
Pediatric Resident, Department of Pediatric
Hasanuddin University