Nutritional Assessment Tool and Nutritional Intervention in Childhood Chronic Liver Disease

Not Applicable

Completed

• Conditions: Chronic Liver Disease
• Interventions: Dietary Supplement: Nutritional Supplement; Dietary Supplement: Standard Nutritional Treatment

• Registration Number: NCT02715973
• Lead Sponsor: Institute of Liver and Biliary Sciences, India

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-01
• Study First Submitted: 2016-02-17
• Study First Submitted QC: 2016-03-16
• Study First Posted: 2016-03-22
• Primary Completion: 2017-10-31
• Study Completion: 2017-10-31
• Status Verified: 2017-12
• Last Update Submitted: 2018-12-04
• Last Update Posted: 2018-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nutritional Supplement	Nutritional Supplement	Diet Counseling (Energy=200 kcal/kg/day, (present weight) protein =3-4 gm/kg/day) Nutritional supplement (Providing extra 40 kcal/kg/day)
Standard nutritional treatment	Standard Nutritional Treatment	Diet counselling only (Energy=200 kcal/kg/day (present weight) protein =3-4 gm/kg/day). Standard nutritional treatment

Primary Outcome Measures

Name	Time	Method
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 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 outcome in children with infantile cholestasis syndrome	1 year	Outcome is defined as survival with native liver, death or liver transplantation

Secondary Outcome Measures

Name	Time	Method
To study the levels of IL-6 before & after nutritional therapy in malnourished children with Chronic Liver Disease	1 year

Trial Locations

Locations (1)

Institute of liver and Biliary Sciences; 🇮🇳 New Delhi, Delhi, India