Clinical trial NCT05724485: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Muscle Cramp
Cirrhosis
Quality of Life
Keywords: Muscle Cramp
cirrhosis
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2023-02-13
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change of muscle cramp frequency
timeFrame: 12 weeks
Secondary outcomes:
measure: Change of muscle cramp duration
timeFrame: 12 weeks
measure: Change of muscle cramp severity
timeFrame: 12 weeks
measure: Quality of life in cirrhotic patients with muscle cramps
timeFrame: 12 weeks
measure: Muscle mass in cirrhotic patients with muscle cramps
timeFrame: 12 weeks
measure: Muscle strengthening in cirrhotic patients with muscle cramps
timeFrame: 12 weeks
measure: Serum albumin
timeFrame: 12 weeks
measure: Serum alanine aminotransferase
timeFrame: 12 weeks
measure: Serum aspartate aminotransferase
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Bangkok Noi
country: Thailand
facility: Faculty of Medicine Siriraj Hospital, Mahidol University
state: Bangkok
Study officials:
affiliation: 66643249159
name: Siwaporn Chainuvati, Asso Prof
role: PRINCIPAL_INVESTIGATOR
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