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

Primary Purpose

Muscle Cramp, Cirrhosis, Quality of Life

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Branched-chain Amino Acid
Placebo
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Muscle Cramp focused on measuring Muscle Cramp, cirrhosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    BCAA group

    Placebo group

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Change of muscle cramp duration
    Change from baseline in muscle cramp duration by patient's diary record as minutes per muscle cramp events
    Change of muscle cramp severity
    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).
    Quality of life in cirrhotic patients with muscle cramps
    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".
    Muscle mass in cirrhotic patients with muscle cramps
    Change of muscle mass in cirrhotic patients with muscle cramps at the end of the study compared to baseline by bioelectrical impedance analysis (BIA)
    Muscle strengthening in cirrhotic patients with muscle cramps
    Change of muscle strength in cirrhotic patients with muscle cramps at the end of the study compared to baseline by hand grip strength measurement
    Serum albumin
    Change of serum albumin (g/dL) in cirrhotic patients with muscle cramps at the end of the study compared to baseline
    Serum alanine aminotransferase
    Change of serum alanine aminotransferase in cirrhotic patients with muscle cramps at the end of the study compared to baseline
    Serum aspartate aminotransferase
    Change of serum aspartate aminotransferase in cirrhotic patients with muscle cramps at the end of the study compared to baseline

    Full Information

    First Posted
    February 1, 2023
    Last Updated
    February 9, 2023
    Sponsor
    Mahidol University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05724485
    Brief Title
    Effect of Branched-chain Amino Acids (BCAA) to Muscle Cramps in Patients With Cirrhosis
    Official Title
    Effect of Branched-chain Amino Acids (BCAA) to Muscle Cramps in Patients With Cirrhosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 1, 2023 (Anticipated)
    Primary Completion Date
    August 31, 2023 (Anticipated)
    Study Completion Date
    September 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Mahidol University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Muscle Cramp, Cirrhosis, Quality of Life
    Keywords
    Muscle Cramp, cirrhosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Masking Description
    All participants will be randomized to receive BCAA or placebo. The BCAA and placebo were prepared by pharmacists who contained both 12.45 grams of BCAA and placebo in the same quantity, the same containing sachet, and labeled enveloped from No.1 to No.50. The sequence of labels was randomized by computer generator block of 4 randomizations with conceal allocation to investigators, participants, care providers, and outcomes assessor.
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    BCAA group
    Arm Type
    Active Comparator
    Arm Description
    12.45 grams of branched-chain amino acids orally per day before bedtime for 12 weeks.
    Arm Title
    Placebo group
    Arm Type
    Placebo Comparator
    Arm Description
    12.45 grams of placebo (Maltodextrin) orally per day before bedtime for 12 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Branched-chain Amino Acid
    Intervention Description
    12.45 grams of BCAA orally per day before bedtime
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Other Intervention Name(s)
    Maltodextrin
    Intervention Description
    12.45 grams of Maltodextrin orally per day before bedtime
    Primary Outcome Measure Information:
    Title
    Change of muscle cramp frequency
    Description
    Change from baseline in muscle cramp frequency by patient's diary record
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Change of muscle cramp duration
    Description
    Change from baseline in muscle cramp duration by patient's diary record as minutes per muscle cramp events
    Time Frame
    12 weeks
    Title
    Change of muscle cramp severity
    Description
    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).
    Time Frame
    12 weeks
    Title
    Quality of life in cirrhotic patients with muscle cramps
    Description
    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".
    Time Frame
    12 weeks
    Title
    Muscle mass in cirrhotic patients with muscle cramps
    Description
    Change of muscle mass in cirrhotic patients with muscle cramps at the end of the study compared to baseline by bioelectrical impedance analysis (BIA)
    Time Frame
    12 weeks
    Title
    Muscle strengthening in cirrhotic patients with muscle cramps
    Description
    Change of muscle strength in cirrhotic patients with muscle cramps at the end of the study compared to baseline by hand grip strength measurement
    Time Frame
    12 weeks
    Title
    Serum albumin
    Description
    Change of serum albumin (g/dL) in cirrhotic patients with muscle cramps at the end of the study compared to baseline
    Time Frame
    12 weeks
    Title
    Serum alanine aminotransferase
    Description
    Change of serum alanine aminotransferase in cirrhotic patients with muscle cramps at the end of the study compared to baseline
    Time Frame
    12 weeks
    Title
    Serum aspartate aminotransferase
    Description
    Change of serum aspartate aminotransferase in cirrhotic patients with muscle cramps at the end of the study compared to baseline
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Thanapat Atthakitmongkol, MD
    Phone
    66813998583
    Email
    ben02170@hotmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Siwaporn Chainuvati, Asso Prof
    Phone
    66643249159
    Email
    schain111@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Siwaporn Chainuvati, Asso Prof
    Organizational Affiliation
    66643249159
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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

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