Nutritional Assessment Tool and Nutritional Intervention in Childhood Chronic Liver Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Liver Disease
- Sponsor
- Institute of Liver and Biliary Sciences, India
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- To study the effect of special fortified indigenous diet on hepatic morbidity in children with infantile cholestasis syndrome
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •Any metabolic or endocrinal diseases independently affecting nutritional status
- •Refusal to give written informed consent to participate in the study
Outcomes
Primary Outcomes
To study the effect of special fortified indigenous diet on hepatic morbidity in children with infantile cholestasis syndrome
Time Frame: 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
Time Frame: 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
Time Frame: 1 year
Outcome is defined as survival with native liver, death or liver transplantation
Secondary Outcomes
- To study the levels of IL-6 before & after nutritional therapy in malnourished children with Chronic Liver Disease(1 year)