Short Term Feeding for Asian Patients With Liver Cirrhosis

This study has been completed.
Sponsor:
Information provided by:
University of Malaya
ClinicalTrials.gov Identifier:
NCT01165073
First received: July 16, 2010
Last updated: February 27, 2011
Last verified: July 2010
  Purpose

The benefits of short-term naso-gastric feeding in patients with advanced cirrhosis remain uncertain. This was a randomised study comparing naso-gastric feeding and oral feeding in Asian patients with cirrhosis who were admitted to hospital for decompensation.


Condition Intervention
CIRRHOSIS
Dietary Supplement: Osmolite and B.C.A.A.
Dietary Supplement: Normal oral intake & supplementation if necessary

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Short Term Feeding for Hospitalised Asian Patients With Liver Cirrhosis - a Randomised Trial of Naso-gastric vs Oral Feeding

Resource links provided by NLM:


Further study details as provided by University of Malaya:

Primary Outcome Measures:
  • Improvement in Child-Pugh score [ Time Frame: Up to 6 weeks ] [ Designated as safety issue: No ]
    Change in the Child-Pugh score, assessing liver damage in cirrhosis


Secondary Outcome Measures:
  • Improvement in nutritional parameters [ Time Frame: up to 6 weeks ] [ Designated as safety issue: No ]
    Improvement in nutritional anthropometry and assessment tool markers after intervention


Enrollment: 52
Study Start Date: March 2008
Study Completion Date: May 2010
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Naso-gastric tube feeding Dietary Supplement: Osmolite and B.C.A.A.
Feeding inserted into enteral tubes
Other Name: Enteral supplementation
Active Comparator: Oral feeding Dietary Supplement: Normal oral intake & supplementation if necessary
Enteral nutrition
Other Name: Enteral supplementation

Detailed Description:

Consecutive patients with decompensated cirrhosis who fitted the inclusion criteria, will be randomised to either naso-gastric or oral feeding. Total feeding will be for 2 weeks only. Following intervention specific nutritional and liver-related parameters will be measured during the 2 weeks and up to 6 weeks later. Comparison between both groups will then be made.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with decompensated cirrhosis of any etiology.

Exclusion Criteria:

  • Advanced hepatic encephalopathy,
  • Variceal bleeding,
  • Hepatocellular carcinoma.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01165073

Locations
Malaysia
University of Malaya Medical Centre
Kuala Lumpur, Federal Territory, Malaysia, 59100
Sponsors and Collaborators
University of Malaya
Investigators
Study Director: Sanjiv Mahadeva, MRCP University of Malaya
Principal Investigator: Mei-Ling S Tai, MRCP University of Malaya
  More Information

Publications:
Responsible Party: Dr Sanjiv Mahadeva/ Dr Sharon Tai Mei Ling, University of Malaya
ClinicalTrials.gov Identifier: NCT01165073     History of Changes
Other Study ID Numbers: NGVOC1
Study First Received: July 16, 2010
Last Updated: February 27, 2011
Health Authority: Malaysia: Ministry of Health

Keywords provided by University of Malaya:
Cirrhosis
Malnutrition
Enteral nutrition

Additional relevant MeSH terms:
Liver Cirrhosis
Fibrosis
Liver Diseases
Digestive System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 16, 2014