Nutritional Assessment Tool and Nutritional Intervention in Childhood Chronic Liver Disease

NCT ID: NCT02715973

Last Updated: 2018-12-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-01
• Study Completion Date: 2017-10-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

Nutritional Supplement

Intervention Type: 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.

Standard nutritional treatment

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

Standard nutritional treatment

Group Type: ACTIVE_COMPARATOR

Standard Nutritional Treatment

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Standard Nutritional Treatment

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 3 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Liver and Biliary Sciences, India

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr Seema Alam, MD

Role: STUDY_DIRECTOR

Institute of Liver and Biliary Sciences

Locations

Institute of liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, India

Countries

India

Other Identifiers

ILBS-CLD-Nutrition-01

Identifier Type: -

Identifier Source: org_study_id