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

February 7, 2024 updated by: Watcharasak Chotiyaputta, Mahidol University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Thailand
    • Bangkok
      • Bangkok Noi, Bangkok, Thailand, 10700
        • Faculty of Medicine Siriraj Hospital, Mahidol University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: BCAA group
12.45 grams of branched-chain amino acids orally per day before bedtime for 12 weeks.
Drug: Branched-chain Amino Acid
12.45 grams of BCAA orally per day before bedtime
Placebo Comparator: Placebo group
12.45 grams of placebo (Maltodextrin) orally per day before bedtime for 12 weeks.
Drug: Placebo
12.45 grams of Maltodextrin orally per day before bedtime
Other Names:
  • Maltodextrin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of muscle cramp frequency
Time Frame: 12 weeks
Change from baseline in muscle cramp frequency by patient's diary record
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 weeks
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).
12 weeks
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".
12 weeks
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)
12 weeks
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
12 weeks
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
12 weeks
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
12 weeks
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
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Investigators

  • Principal Investigator: Siwaporn Chainuvati, Asso Prof, 66643249159

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Actual)

October 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

February 1, 2023

First Submitted That Met QC Criteria

February 9, 2023

First Posted (Actual)

February 13, 2023

Study Record Updates

Last Update Posted (Estimated)

February 9, 2024

Last Update Submitted That Met QC Criteria

February 7, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Si 1071/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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