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Clinical Trials/NCT02715973
NCT02715973
Completed
Not Applicable

Nutritional Assessment Tool and Nutritional Intervention in Childhood Chronic Liver Disease

Institute of Liver and Biliary Sciences, India1 site in 1 country40 target enrollmentJanuary 1, 2016

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).

Registry
clinicaltrials.gov
Start Date
January 1, 2016
End Date
October 31, 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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)

Study Sites (1)

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