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

• Status: Not yet recruiting
• Trial end date: 2023-09-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mahidol University

Criteria

Inclusion Criteria:

• Age ≥ 18 years

• Muscle cramp ≥ 1 time per week

• Confirmed cirrhotic status (radiologic finding compatible with cirrhosis or liver stiffness measurement ≥ 12.5 kPa by transient elastography method or pathological confirm of cirrhosis)

Exclusion Criteria:

• Allergy to BCAA

• Overt hepatic encephalopathy

• Hepatorenal syndrome

• Severe renal insufficiency; eGFR < 30

• Heart failure

• Peripheral arterial disease

• Active malignancies beyond hepatocellular carcinoma

• Heavy alcohol drinking (> 21g/day for men and >14g/day for women)

• Pregnancy or lactation

• Current use of BCAA within 3 months

• Recent adding or titrating diuretics within 4 weeks

• On current medications for muscle cramp relief such as vitamin E, taurine, carnitine, narcotic pain medications, baclofen, methocarbamol, other muscle relaxers, NSAIDs, or other antispastic agents.