Nutritional Assessment Tool and Nutritional Intervention in Childhood Chronic Liver Disease

• Sponsor: Institute of Liver and Biliary Sciences, India (Other)
• Overall Status: Completed
• CT.gov ID: NCT02715973
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Actual Duration (Months): 22
• Patients Per Site Per Month: 1.8

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Chronic Liver Disease	Dietary Supplement: Nutritional Supplement; Dietary Supplement: Standard Nutritional Treatment	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Nutritional Assessment Tool and Nutritional Intervention in Childhood Chronic Liver Disease
• Actual Study Start Date: Jan 1, 2016
• Actual Primary Completion Date: Oct 31, 2017
• Actual Study Completion Date: Oct 31, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

3. 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

1. To study the levels of IL-6 before & after nutritional therapy in malnourished children with Chronic Liver Disease [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Months to 3 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute of liver and Biliary Sciences	New Delhi	Delhi	India	110070

Sponsors and Collaborators

• Institute of Liver and Biliary Sciences, India

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Institute of Liver and Biliary Sciences, India
• ClinicalTrials.gov Identifier: NCT02715973
• Other Study ID Numbers: ILBS-CLD-Nutrition-01
• First Posted: Mar 22, 2016
• Last Update Posted: Dec 6, 2018
• Last Verified: Dec 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Additional relevant MeSH terms: Liver Diseases

Study Results

No Results Posted as of Dec 6, 2018