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

Mahidol University

Status and phase: Completed; Phase 4

Conditions: Quality of Life; Cirrhosis; Muscle Cramp

Treatments: Drug: Placebo; Drug: Branched-chain Amino Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT05724485

Si 1071/2020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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48 participants in 2 patient groups, including a placebo group

BCAA group

Active Comparator group

Description:

12.45 grams of branched-chain amino acids orally per day before bedtime for 12 weeks.

Treatment:

Drug: Branched-chain Amino Acid

Placebo group

Placebo Comparator group

Description:

12.45 grams of placebo (Maltodextrin) orally per day before bedtime for 12 weeks.

Treatment:

Drug: Placebo