ClinicalTrials.gov
ClinicalTrials.gov Menu

Nutritional Assessment Tool and Nutritional Intervention in Childhood Chronic Liver Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02715973
Recruitment Status : Recruiting
First Posted : March 22, 2016
Last Update Posted : May 30, 2018
Sponsor:
Information provided by (Responsible Party):
Institute of Liver and Biliary Sciences, India

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 Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated 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
Study Start Date : January 2016
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. To study the effect of special fortified indigenous diet on growth,and outcome in children with infantile cholestasis syndrome [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 1 year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   3 Months to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02715973


Contacts
Contact: Dr Arti Pawaria, MD 011-46300000 artipawaria@gmail.com

Locations
India
Institute of liver and Biliary Sciences Recruiting
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

Responsible Party: Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier: NCT02715973     History of Changes
Other Study ID Numbers: ILBS-CLD-Nutrition-01
First Posted: March 22, 2016    Key Record Dates
Last Update Posted: May 30, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases