Chronic Liver Disease Clinical Trial
Official title:
Nutritional Assessment Tool and Nutritional Intervention in Childhood Chronic Liver Disease
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).
n/a
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