- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02715973
Nutritional Assessment Tool and Nutritional Intervention in Childhood Chronic Liver Disease
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).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Delhi
-
New Delhi, Delhi, India, 110070
- Institute of liver and Biliary Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Any metabolic or endocrinal diseases independently affecting nutritional status
- Refusal to give written informed consent to participate in the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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) |
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 |
Standard nutritional counseling by a trained dietician as per the recommended daily allowance according to gender and age
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 year
|
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.
|
1 year
|
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
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To study the levels of IL-6 before & after nutritional therapy in malnourished children with Chronic Liver Disease
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
Investigators
- Study Director: Dr Seema Alam, MD, Institute of liver and Biliary Sciences
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ILBS-CLD-Nutrition-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Liver Disease
-
First Affiliated Hospital of Zhejiang UniversityCompletedAcute-On-Chronic Liver Failure | Cirrhosis and Chronic Liver Disease
-
Chuncheon Sacred Heart HospitalSuspendedChronic Liver Disease | Acute Derangement of Liver FunctionKorea, Republic of
-
Assiut UniversityCompletedAcute-On-Chronic Liver FailureEgypt
-
Third Affiliated Hospital, Sun Yat-Sen UniversityWithdrawnLiver Failure, Acute on ChronicChina
-
Shanghai Jiao Tong University School of MedicineNot yet recruitingChronic Liver Disease and CirrhosisChina
-
Beijing 302 HospitalShenzhen Third People's Hospital; Shulan (Hang Zhou) Hospital; BeijingYouan Hospital and other collaboratorsNot yet recruitingAcute-On-Chronic Liver FailureChina
-
Tianjin Weikai Bioeng., Ltd.Tianjin Nankai HospitalUnknownLiver Failure, Acute on ChronicChina
-
Chulalongkorn UniversityRecruitingAcute-On-Chronic Liver Failure | Acute on Chronic Hepatic FailureThailand
-
Daewoong Pharmaceutical Co. LTD.Enrolling by invitationChronic Liver DiseaseKorea, Republic of
-
Meridian Bioscience, Inc.CompletedChronic Liver DiseaseUnited States, Israel
Clinical Trials on Nutritional Supplement
-
Asan Medical CenterUnknown
-
Abbott NutritionChangi General Hospital; SingHealth PolyclinicsCompletedMalnutritionSingapore
-
Taipei Medical UniversityMeiji Co., Ltd.CompletedMalnutrition ElderlyTaiwan
-
Abbott NutritionWithdrawn
-
PharmanexDermatology Consulting Services, High Point NCCompletedSkin HealthUnited States
-
AHS Cancer Control AlbertaCross Cancer InstituteWithdrawn
-
National Institute on Aging (NIA)Burke Medical Research InstituteCompletedAlzheimer DiseaseUnited States
-
Abbott NutritionCompleted
-
Philipp SchuetzRecruiting
-
Dialysis Clinic, Inc.UnknownEnd Stage Renal Disease