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Completed

NCT Number: NCT05724485

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok Noi, Bangkok, 10700, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Branched-chain amino acid

Drug

12.45 grams of BCAA orally per day before bedtime

Placebo

Drug

12.45 grams of Maltodextrin orally per day before bedtime

Other names: Maltodextrin

Primary outcomes

  1. Change of muscle cramp frequency

    Time frame: 12 weeks

    Change from baseline in muscle cramp frequency by patient's diary record

Secondary outcomes

  1. Change of muscle cramp duration

    Time frame: 12 weeks

    Change from baseline in muscle cramp duration by patient's diary record as minutes per muscle cramp events

  2. Change of muscle cramp severity

    Time frame: 12 weeks

    Change from baseline in muscle cramp severity by patient's diary record as the visual analog scale that reported from 0 (no pain) to 10 (worst pain).

  3. Quality of life in cirrhotic patients with muscle cramps

    Time frame: 12 weeks

    Change of quality of life in cirrhotic patients with muscle cramps at the end of the study compared to baseline by chronic liver disease questionnaire (CLDQ) that includes 29 items in the following domains: abdominal symptoms, fatigue, systemic symptoms, activity, emotional function, and worry. The response of CLDQ results in 1 to 7 scales: ranging from "all of the time" to "none of the time".

  4. Muscle mass in cirrhotic patients with muscle cramps

    Time frame: 12 weeks

    Change of muscle mass in cirrhotic patients with muscle cramps at the end of the study compared to baseline by bioelectrical impedance analysis (BIA)

  5. Muscle strengthening in cirrhotic patients with muscle cramps

    Time frame: 12 weeks

    Change of muscle strength in cirrhotic patients with muscle cramps at the end of the study compared to baseline by hand grip strength measurement

  6. Serum albumin

    Time frame: 12 weeks

    Change of serum albumin (g/dL) in cirrhotic patients with muscle cramps at the end of the study compared to baseline

  7. Serum alanine aminotransferase

    Time frame: 12 weeks

    Change of serum alanine aminotransferase in cirrhotic patients with muscle cramps at the end of the study compared to baseline

  8. Serum aspartate aminotransferase

    Time frame: 12 weeks

    Change of serum aspartate aminotransferase in cirrhotic patients with muscle cramps at the end of the study compared to baseline

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 13, 2023
Registry last updated
Feb 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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