Status:
ENROLLING_BY_INVITATION
Oral Branched-chain Amino Acid Supplementation for Cirrhotic Patients With Sarcopenia
Lead Sponsor:
Mahidol University
Conditions:
Sarcopenia
Cirrhosis of the Liver
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief Summary
The goal of this clinical trial is to compare the nutritional parameters after 24-week supplementation of branched-chain amino acids in cirrhotic patients with low muscle mass. The main questions it ...
Detailed Description
The goal of this clinical trial is to compare the nutritional parameters after 24-week supplementation of branched-chain amino acids in cirrhotic patients with low muscle mass. The main questions it ...
Eligibility Criteria
Inclusion
- Patients aged between 18 and 85 years.
- Patients who have been diagnosed with liver cirrhosis due to any etiology.
- Patients with sarcopenia as determined by a computed tomography scan within the last 3 months. For males, sarcopenia is defined as a Skeletal Muscle Index (SMI) less than 42 cm²/m², and for females, an SMI less than 38 cm²/m²
Exclusion
- Patients with hepatocellular carcinoma outside the Milan criteria.
- Patients with Overt Hepatic Encephalopathy or gastrointestinal bleeding within the last 6 months.
- Patients with refractory ascites (ascites that does not respond to treatment).
- Patients in the advanced stage of cirrhosis with Child-Turcotte-Pugh (CTP) score C.
- Patients with acute-on-chronic liver failure (ACLF).
- Patients with uncontrollable decompensated comorbidities, including chronic heart failure classified as NYHA 3-4, patients with kidney disease requiring dialysis, patients with severe obstructive lung disease classified as Gold D, patients with other non-liver cancers requiring chemotherapy, and patients with chronic infections such as tuberculosis.
- Patients who have previously undergone liver or kidney transplantation.
- Patients with Human Immunodeficiency Virus (HIV) infection.
- Pregnant or breastfeeding patients.
Key Trial Info
Start Date :
November 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT06121492
Start Date
November 15 2023
End Date
June 30 2026
Last Update
September 29 2025
Active Locations (1)
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1
Division of Gastroenterology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand
Bangkok, Bangkok, Thailand, 10700