- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02802761
Nutritional Assessment Tool in Childhood Chronic Liver Disease
December 4, 2018 updated by: Institute of Liver and Biliary Sciences, India
Study Cohort:
All Children (Age: 3 months- 18 years, corrected age upto 2 years for preterm children) with Chronic Liver Disease attending Pediatric Hepatology Out Patient Department/In Patient Department
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Delhi
-
New Delhi, Delhi, India, 110070
- Institute of liver and Biliary Sciences
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 months to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All Children (Age: 3 months to 18 years, corrected age upto 2 years for preterm children) with CLD attending Pediatric Hepatology OPD/IPD.
Description
Inclusion Criteria:
- Children from age of 3 months- 18 years (corrected age upto 2 years for preterm children)
- Chronic liver disease.
Exclusion Criteria:
- Any metabolic or endocrinal diseases independently affecting nutritional status
- Refusal to give written informed consent to participate in the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reliability of SGNA versus nutritional status as assessed by standard anthropometric measures in children with chronic liver disease.
Time Frame: 2 years
|
Nutritional status (well nourished, moderate or severe malnutrition) of a child with chronic liver disease as assessed by standard anthropometric measures (weight, height, mid arm circumference, Body mass index, triceps and subscapular skin fold thickness) will be compared to the results of nutritional assessment score as obtained by applying Subjective Global Nutritional Assessment (SGNA) proforma.
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Dr Seema Alam, MD, Institute of liver and Biliary Sciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2016
Primary Completion (Actual)
October 31, 2017
Study Completion (Actual)
October 31, 2017
Study Registration Dates
First Submitted
March 21, 2016
First Submitted That Met QC Criteria
June 15, 2016
First Posted (Estimate)
June 16, 2016
Study Record Updates
Last Update Posted (Actual)
December 6, 2018
Last Update Submitted That Met QC Criteria
December 4, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ILBS-CLD-Nutrition-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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