An interventional study of Nutritional Supplement and Standard Nutritional Treatment in Chronic Liver Disease, sponsored by Institute of Liver and Biliary Sciences, India. Completed at 1 site in India. Open to participants aged 3 Months to 3 Years. Per ClinicalTrials.gov, last updated 2018-12-06.
Sponsored by Institute of Liver and Biliary Sciences, India · Not applicable, Interventional, and Treatment
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).
2,080 studies on the registry are indexed under Liver Diseases; 389 are open to participants now.
This study's enrollment of 40 is below the median of 50 across 1,322 interventional studies indexed under Liver Diseases.
Browse Liver Diseases studies →Institute of Liver and Biliary Sciences, India is the lead sponsor of 296 studies on the registry; 84 are open to participants now.
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Exclusion Criteria:
Diet Counseling (Energy=200 kcal/kg/day, (present weight) protein =3-4 gm/kg/day) Nutritional supplement (Providing extra 40 kcal/kg/day)
Dietary Supplement: Nutritional Supplement
Diet counselling only (Energy=200 kcal/kg/day (present weight) protein =3-4 gm/kg/day). Standard nutritional treatment
Dietary Supplement: Standard Nutritional Treatment
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.
Standard nutritional counseling by a trained dietician as per the recommended daily allowance according to gender and age
To study the effect of special fortified indigenous diet on growth,and outcome in children with infantile cholestasis syndrome
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.
Time frame: 1 year
To study the effect of special fortified indigenous diet on hepatic morbidity in children with infantile cholestasis syndrome
hepatic morbidity is a composite outcome comprising of ascites, hepatic encephalopathy, spontaneous bacterial peritonitis, intercurrent infections, variceal bleed.
Time frame: 1 year
To study the effect of special fortified indigenous diet on outcome in children with infantile cholestasis syndrome
Outcome is defined as survival with native liver, death or liver transplantation
Time frame: 1 year
To study the levels of IL-6 before & after nutritional therapy in malnourished children with Chronic Liver Disease
Time frame: 1 year
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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Institute of Liver and Biliary Sciences, India