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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02715973
Other study ID # ILBS-CLD-Nutrition-01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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