Chronic Liver DiseaseNCT02802761
Nutritional Assessment Tool in Childhood Chronic Liver Disease
An observational study of Chronic Liver Disease, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 3 months to 18 years
- Conditions the study is for
- Chronic Liver Disease
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jan 2016to 31 Oct 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- Children from age of 3 months- 18 years (corrected age upto 2 years for preterm children)
- Chronic liver disease.
Who cannot join
- Any metabolic or endocrinal diseases independently affecting nutritional status
- Refusal to give written informed consent to participate in the study
Trial locations and contacts
1 site in 1 country.
India1 site
Institute of liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
About this study
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
- Conditions
- Chronic Liver Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Reliability of SGNA versus nutritional status as assessed by standard anthropometric measures in children with chronic liver disease.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2016 (estimated)
- Study start1 Jan 2016
- Primary completion31 Oct 2017
- Study completion31 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Seema Alam, MD, Study director, Institute of Liver and Biliary Sciences, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02802761
- Sponsor's protocol ID
- ILBS-CLD-Nutrition-02
- Status last verified
- May 2018
- First submitted
- 21 Mar 2016
- Last updated
- 6 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Assessment Tool in Childhood Chronic Liver Disease
- ClinicalTrials.gov ID
- NCT02802761
- Acronym / sponsor ID
- ILBS-CLD-Nutrition-02
- Conditions
- Chronic Liver Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Oct 2017 (actual)
- Study completion
- 31 Oct 2017 (actual)
- First posted
- 16 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (2 listed)
- Children from age of 3 months- 18 years (corrected age upto 2 years for preterm children)
- Chronic liver disease.
Key exclusion criteria (2 listed)
- Any metabolic or endocrinal diseases independently affecting nutritional status
- Refusal to give written informed consent to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Seema Alam, MD study director
Institute of Liver and Biliary Sciences, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Liver Disease, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reliability of SGNA versus nutritional status as assessed by standard anthropometric measures in children with chronic liver disease. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2018.