NCT05724485

Effect of Branched-chain Amino Acids (BCAA) to Muscle Cramps in Patients With Cirrhosis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Mahidol University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The goal of this randomized controlled trial is to compare the efficacy and safety of branched-chain amino acids (BCAA) versus placebo for treating muscle cramps in cirrhotic patients. The main questions it aims to answer are: * Compared the effect of BCAA versus placebo on muscle cramp frequency in cirrhotic patients * Compared the effect of BCAA versus placebo on muscle cramp duration and severity in cirrhotic patients * Compared the effect of BCAA versus placebo on quality of life in cirrhotic patients with muscle cramps Participants with cirrhosis who have experienced muscle cramps at least once per week will be randomized to receive either a placebo or 12.45 grams of BCAA orally per day for 12 weeks.

Detailed description

Cirrhosis is a late-stage of fibrosis of the liver caused by many forms of liver disease. Muscle cramps are visible or palpable involuntary contraction part of the muscle. The prevalence of cramps in cirrhosis varied range from 31-78%. The pathophysiology of cramps in cirrhosis was explained by multiple mechanisms such as energy metabolism, nerve function, and plasma volume. Cramps significantly diminished the quality of life in cirrhotic patients. Many drugs, vitamins, and minerals were studied for treating cramps in cirrhosis in previous studies but no clinical improvement, good randomized control studies, or side effects. Branched-chain amino acids (BCAA) had been developed to correct this amino acid imbalance and helped to decrease the frequency of cramps and improve the quality of life in cirrhotic patients from previous studies but there were no control groups and a small number of patients were included. The aim of this study was to evaluate the efficacy and safety of BCAA for controlling muscle cramps in cirrhotic patients.

Conditions

• Muscle Cramp
• Cirrhosis
• Quality of Life

Interventions

Type	Name	Description
DRUG	Branched-chain Amino Acid	12.45 grams of BCAA orally per day before bedtime
DRUG	Placebo	12.45 grams of Maltodextrin orally per day before bedtime

Timeline

• Start date: 2023-04-01
• Primary completion: 2023-10-31
• Completion: 2023-12-31
• First posted: 2023-02-13
• Last updated: 2024-02-09

Locations

1 site across 1 country: Thailand