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

NCT05724485 | Completed Phase 4 DMC

• 1 other identifier: Si 1071/2020
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Muscle Cramp; Cirrhosis; Quality of Life

Keywords

Muscle Cramp; cirrhosis

Outcome Measures

Primary Outcomes (1)

• Change of muscle cramp frequency

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

  12 weeks

Secondary Outcomes (8)

• Change of muscle cramp duration

  12 weeks

• Change of muscle cramp severity

  12 weeks

• Quality of life in cirrhotic patients with muscle cramps

  12 weeks

• Muscle mass in cirrhotic patients with muscle cramps

  12 weeks

• Muscle strengthening in cirrhotic patients with muscle cramps

  12 weeks

Study Arms (2)

BCAA group

ACTIVE COMPARATOR

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

Drug: Branched-chain Amino Acid

Placebo group

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Branched-chain Amino Acid DRUG

12.45 grams of BCAA orally per day before bedtime

BCAA group

Placebo DRUG

12.45 grams of Maltodextrin orally per day before bedtime

Also known as: Maltodextrin

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok Noi, Bangkok, 10700, Thailand

Location

Related Publications (23)

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• Sako K, Imamura Y, Nishimata H, Tahara K, Kubozono O, Tsubouchi H. Branched-chain amino acids supplements in the late evening decrease the frequency of muscle cramps with advanced hepatic cirrhosis. Hepatol Res. 2003 Aug;26(4):327-329. doi: 10.1016/s1386-6346(03)00152-9.

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• Younossi ZM, Guyatt G, Kiwi M, Boparai N, King D. Development of a disease specific questionnaire to measure health related quality of life in patients with chronic liver disease. Gut. 1999 Aug;45(2):295-300. doi: 10.1136/gut.45.2.295.

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  PMID: 21563202 RESULT

• Abd-Elsalam S, Arafa M, Elkadeem M, Elfert A, Soliman S, Elkhalawany W, Badawi R. Randomized-controlled trial of methocarbamol as a novel treatment for muscle cramps in cirrhotic patients. Eur J Gastroenterol Hepatol. 2019 Apr;31(4):499-502. doi: 10.1097/MEG.0000000000001310.

  PMID: 30444744 RESULT

• Elfert AA, Abo Ali L, Soliman S, Zakaria S, Shehab El-Din I, Elkhalawany W, Abd-Elsalam S. Randomized placebo-controlled study of baclofen in the treatment of muscle cramps in patients with liver cirrhosis. Eur J Gastroenterol Hepatol. 2016 Nov;28(11):1280-4. doi: 10.1097/MEG.0000000000000714.

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MeSH Terms

Conditions

Muscle Cramp; Fibrosis

Interventions

Amino Acids, Branched-Chain; maltodextrin

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Siwaporn Chainuvati, Asso Prof

  66643249159

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, Faculty of Medicine, Siriraj Hospital

Study Record Dates

• First Submitted: February 1, 2023
• First Posted: February 13, 2023
• Study Start: April 1, 2023
• Primary Completion: October 31, 2023
• Study Completion: December 31, 2023
• Last Updated: February 9, 2024

Record last verified: 2024-02

Locations

TH (1)