Chronic Liver Disease
Conditions
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).
Interventions
DIETARY_SUPPLEMENTNutritional 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 as per the recommended daily allowance according to gender and age.
DIETARY_SUPPLEMENTStandard Nutritional Treatment
Standard nutritional counseling by a trained dietician as per the recommended daily allowance according to gender and age
Sponsors
Institute of Liver and Biliary Sciences, India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Months to 3 Years
Healthy volunteers
No
Inclusion criteria
1. 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) 2. Hindi/English speaking family
Exclusion criteria
1. Any metabolic or endocrinal diseases independently affecting nutritional status 2. Refusal to give written informed consent to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To study the effect of special fortified indigenous diet on growth,and outcome in children with infantile cholestasis syndrome | 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 hepatic morbidity in children with infantile cholestasis syndrome | 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 outcome in children with infantile cholestasis syndrome | 1 year | Outcome is defined as survival with native liver, death or liver transplantation |
Secondary
| Measure | Time frame |
|---|---|
| To study the levels of IL-6 before & after nutritional therapy in malnourished children with Chronic Liver Disease | 1 year |
Countries
India
Outcome results
None listed