Nutritional Assessment Tool and Nutritional Intervention in Childhood Chronic Liver Disease

Chronic Liver Disease Clinical Trial

Official title:

Nutritional Assessment Tool and Nutritional Intervention in Childhood Chronic Liver Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02715973
• Other study ID #: ILBS-CLD-Nutrition-01
• Status: Completed
• Phase: N/A
• Start date: January 1, 2016
• Est. completion date: October 31, 2017

Study information

• Verified date: December 2017
• Source: Institute of Liver and Biliary Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 31, 2017
• Est. primary completion date: October 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 3 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Liver Disease
• Liver Diseases

Intervention

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.
• Standard Nutritional Treatment
Standard nutritional counseling by a trained dietician as per the recommended daily allowance according to gender and age

Locations

Country	Name	City	State
India	Institute of liver and Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	To study the levels of IL-6 before & after nutritional therapy in malnourished children with Chronic Liver Disease		1 year