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).

Study Overview

• Status: Completed
• Conditions: Chronic Liver Disease
• Intervention / Treatment: Dietary supplement: Nutritional Supplement; Dietary supplement: Standard Nutritional Treatment

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110070
      • Institute of Liver and Biliary Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	Dietary supplement: 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 as per the recommended daily allowance according to gender and age.
Active Comparator: Standard nutritional treatment; Diet counselling only (Energy=200 kcal/kg/day (present weight) protein =3-4 gm/kg/day). Standard nutritional treatment	Dietary supplement: Standard Nutritional Treatment; Standard nutritional counseling by a trained dietician as per the recommended daily allowance according to gender and age

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India
• Investigators: Study Director: Dr Seema Alam, MD, Institute of Liver and Biliary Sciences

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): October 31, 2017
• Study Completion (Actual): October 31, 2017

Study Registration Dates

• First Submitted: February 17, 2016
• First Submitted That Met QC Criteria: March 16, 2016
• First Posted (Estimate): March 22, 2016

Study Record Updates

• Last Update Posted (Actual): December 6, 2018
• Last Update Submitted That Met QC Criteria: December 4, 2018
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases
• Other Study ID Numbers: ILBS-CLD-Nutrition-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED