Nutritional Assessment Tool and Nutritional Intervention in Childhood Chronic Liver Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- To study the effect of special fortified indigenous diet on hepatic morbidity in children with infantile cholestasis syndrome
研究概览
简要总结
Children (Exclusively breast fed: 6mo - 3yrs, and who are not exclusively breast fed 3mo to 3 yrs) with infantile cholestasis syndrome will be randomized to either recieve indigenously prepared oral nutritional supplement (energy dense supplement appox. 2 kcal/mL, prepared from locally available, affordable, socially acceptable food items - milk, sugar, edible coconut oil, egg and custard powder as base) in addition to standard nutritional counseling by a trained dietician (Group A). The control group (Group B) in comparison will receive standard nutritional counseling from a trained dietician but will not receive any additional nutritional supplement. All the children will be followed up at 1 month, 3 months, 6 months, 9 months and 1 year after inclusion. Clinical, nutritional assessment and laboratory data will be collected at each visit. Additionally IL-6 levels will be done at each visit in children of both arms of the intervention group.
The outcomes of interest will be growth and improvement of nutritional status parameters, hepatic morbidity (ascites, gastrointestinal bleeding, encephalopathy, {SBP (Spontaneous Bacterial Peritonitis), HRS (Hepatorenal Syndrome), etc and outcome (improvement, death or Liver Transplantation}.
All children will receive individualized standard treatment for infantile cholestasis syndrome including vitamin supplements/endotherapy/ beta blockers/ prophylaxis for SBP (Spontaneous Bacterial Peritonitis)/cholangitis (to at risk children) and drug therapy wherever indicated (steroids/ copper chelation/ UDCA).
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
- None
入排标准
- 年龄范围
- 3 Months 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Nutritional intervention in children with moderate and severe malnutrition as pr standard anthropometric measures children (Exclusively breast fed: 6mo - 3yrs, and who are not exclusively breast fed : 3mo to 3 yrs) with infantile cholestasis syndrome)
- •Hindi/English speaking family
排除标准
- •Any metabolic or endocrinal diseases independently affecting nutritional status
- •Refusal to give written informed consent to participate in the study
研究组 & 干预措施
Nutritional Supplement
Diet Counseling (Energy=200 kcal/kg/day, (present weight) protein =3-4 gm/kg/day)
Nutritional supplement (Providing extra 40 kcal/kg/day)
干预措施: Nutritional Supplement (Dietary Supplement)
Standard nutritional treatment
Diet counselling only (Energy=200 kcal/kg/day (present weight) protein =3-4 gm/kg/day).
Standard nutritional treatment
干预措施: Standard Nutritional Treatment (Dietary Supplement)
结局指标
主要结局
To study the effect of special fortified indigenous diet on hepatic morbidity in children with infantile cholestasis syndrome
时间窗: 1 year
hepatic morbidity is a composite outcome comprising of ascites, hepatic encephalopathy, spontaneous bacterial peritonitis, intercurrent infections, variceal bleed.
To study the effect of special fortified indigenous diet on growth,and outcome in children with infantile cholestasis syndrome
时间窗: 1 year
Growth is a composite outcome defines as age and sex appropriate anthropometric measures- weight , height, mid arm circumference, triceps skin fold thickness, subscapular skin fold thickness.
To study the effect of special fortified indigenous diet on outcome in children with infantile cholestasis syndrome
时间窗: 1 year
Outcome is defined as survival with native liver, death or liver transplantation
次要结局
- To study the levels of IL-6 before & after nutritional therapy in malnourished children with Chronic Liver Disease(1 year)