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Oral Branched-chain Amino Acid Supplementation for Decompensated Cirrhotic Patients

StatusEnrolling by Invitation
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Primary completion date changed from estimate of Jun 30, 2025 to Sep 23, 2025 Publications: details revised at 4 of 12 entriesv6 Show 1 more changeShow less
    • Publications: details revised at 4 of 12 entries
  2. Minor Re-verified, no change to tracked fieldsv5
  3. Notable Primary completion date: Jun 30, 2024 to Jun 30, 2025 Trial status: Recruiting to Enrolling by Invitation · Completion date: Dec 31, 2024 to Dec 31, 2025 · Site details revised · 1 morev4 Show 4 more changesShow less
    • Trial status: Recruiting to Enrolling by Invitation
    • Completion date: Dec 31, 2024 to Dec 31, 2025
    • Site details revised
    • Publications: details revised at 4 of 12 entries
  4. Minor Study description shortened, about 6 wordsv3 See this version in full on ClinicalTrials.gov ↗
  5. Notable Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Nov 1, 2023 to Nov 13, 2023 · Site details revisedv2 Show 2 more changesShow less
    • Start date changed from estimate of Nov 1, 2023 to Nov 13, 2023
    • Site details revised
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this clinical trial is to compare the nutritional parameters after 12-week supplementation of branched-chain amino acids in cirrhotic patients with ascites and serum albumin less than 3 g/dL. The main questions it aims to answer are: 1. Would thigh muscle thickness change after 12-week supplementation of branched-chain amino acids in cirrhotic patients with ascites and serum albumin less than 3 g/dL? 2. Would triceps skin fold thickness, mid-arm circumferences, mid-arm muscle circumferences, skeletal muscle mass, appendicular skeletal muscle mass, skeletal muscle index and fat mass change after 12-week supplementation of branched-chain amino acids in cirrhotic patients with ascites and serum albumin less than 3 g/dL? 3. Would handgrip strength change after 12-week supplementation of branched-chain amino acids in cirrhotic patients with ascites and serum albumin less than 3 g/dL? 4. Would serum albumin change after 12-week supplementation of branched-chain amino acids in cirrhotic patients with ascites and serum albumin less than 3 g/dL? 5. Would score for cirrhotic severity such as Model for End-Stage Liver Disease-Sodium Score (MELD-Na score) and Child Turcotte Pugh Score change after 12-week supplementation of branched-chain amino acids in cirrhotic patients with ascites and serum albumin less than 3 g/dL? Participants will be asked to do following tasks: 1. Participants will be asked for basic information such as age, place of residence, and contact telephone number. 2. Participants will undergo measurements of weight, height, body mass index, skinfold thickness on the arms, circumference of the arms and legs, muscle mass, and body fat content using a body composition analyzer, both at the beginning and end of the research study. 3. Participants will perform grip strength measurements, at both the beginning and end of the research study. 4. Participants will undergo laboratory tests, including a complete blood count, liver and kidney function tests, blood clotting factors, and blood mineral levels, with a total blood volume of approximately 15 milliliters (1 tablespoon), collected twice during the study (at the beginning and end). 5. Participants will be administered supplements containing branched-chain amino acids (BCAA) twice a day for a total of 12 weeks. 6. Participants will be appointed for follow-up during the study, totaling 2 appointments at weeks 4 and 12. Side effects related to medication will be asked. 7. Participants will undergo ultrasound measurements of the right thigh to assess thigh muscle thickness, both at the beginning and end of the research study. 8. Participants will will complete questionnaires to assess your overall quality of life twice, both at the beginning and end of the research study.
Trial Details
NCT Number NCT06121479
Lead Sponsor Mahidol University
Conditions Decompensated Cirrhosis and Ascites
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov