Nutritional Assessment Tool and Nutritional Intervention in Childhood Chronic Liver Disease

NCT02715973 | Completed

• 1 other identifier: ILBS-CLD-Nutrition-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Liver Disease

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• To study the levels of IL-6 before & after nutritional therapy in malnourished children with Chronic Liver Disease

  1 year

Study Arms (2)

Nutritional Supplement

EXPERIMENTAL

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

Standard nutritional treatment

ACTIVE COMPARATOR

Diet counselling only (Energy=200 kcal/kg/day (present weight) protein =3-4 gm/kg/day). Standard nutritional treatment

Dietary Supplement: Standard Nutritional Treatment

Interventions

Nutritional Supplement DIETARY_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.

Nutritional Supplement

Standard Nutritional Treatment DIETARY_SUPPLEMENT

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

Standard nutritional treatment

Eligibility Criteria

• Age: 3 Months - 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Any metabolic or endocrinal diseases independently affecting nutritional status
• Refusal to give written informed consent to participate in the study

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Location

MeSH Terms

Interventions

Dietary Supplements

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Dr Seema Alam, MD

  Institute of Liver and Biliary Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2016
• First Posted: March 22, 2016
• Study Start: January 1, 2016
• Primary Completion: October 31, 2017
• Study Completion: October 31, 2017
• Last Updated: December 6, 2018

Record last verified: 2017-12

Locations

IN (1)