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Muscle CrampPhase 4NCT05724485

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

A Phase 4 study testing Branched-chain Amino Acid in people with Muscle Cramp and Cirrhosis, run by Mahidol University at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Muscle Cramp, Cirrhosis, Quality of Life
What is being tested?
Branched-chain Amino Acid
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
48 participants
Where
1 siteThailand
Study dates
1 Apr 2023to 31 Dec 2023
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • Allergy to BCAA
  • Overt hepatic encephalopathy
  • Hepatorenal syndrome
  • Severe renal insufficiency; eGFR < 30
  • Heart failure
  • Peripheral arterial disease
Show all 12Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Thailand1 site

  • Faculty of Medicine Siriraj Hospital, Mahidol University

    Bangkok Noi, Bangkok, 10700

Other trials in Thailand

About this study

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.
Read the 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.

Being tested
Branched-chain Amino Acid, Placebo
Keywords
Muscle Cramp, cirrhosis
Medical subject headings
Muscle Cramp, Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Branched-chain Amino AcidDrug

    12.45 grams of BCAA orally per day before bedtime

  • PlaceboDrug

    Also called Maltodextrin

    12.45 grams of Maltodextrin orally per day before bedtime

Study groups in NCT05724485
Study groupRoleWhat they receive
BCAA groupActive comparator12.45 grams of branched-chain amino acids orally per day before bedtime for 12 weeks.
Receives: Drug: Branched-chain Amino Acid
Placebo groupPlacebo comparator12.45 grams of placebo (Maltodextrin) orally per day before bedtime for 12 weeks.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of muscle cramp frequency

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

    Measured: 12 weeks

Secondary outcomes (8)

  1. Change of muscle cramp duration

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

    Measured: 12 weeks

  2. 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).

    Measured: 12 weeks

  3. 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".

    Measured: 12 weeks

  4. 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)

    Measured: 12 weeks

  5. 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

    Measured: 12 weeks

  6. Serum albumin

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

    Measured: 12 weeks

  7. Serum alanine aminotransferase

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

    Measured: 12 weeks

  8. Serum aspartate aminotransferase

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

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2023
  2. Study start1 Apr 2023
  3. Primary completion31 Oct 2023
  4. Study completion31 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05724485
Sponsor's protocol ID
Si 1071/2020
Status last verified
Feb 2024
First submitted
1 Feb 2023
Last updated
9 Feb 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Chatrath H, Liangpunsakul S, Ghabril M, Otte J, Chalasani N, Vuppalanchi R. Prevalence and morbidity associated with muscle cramps in patients with cirrhosis. Am J Med. 2012 Oct;125(10):1019-25. doi: 10.1016/j.amjmed.2012.03.012. Epub 2012 Jul 24.

    PubMed 22835465

  • Mehta SS, Fallon MB. Muscle cramps in liver disease. Clin Gastroenterol Hepatol. 2013 Nov;11(11):1385-91; quiz e80. doi: 10.1016/j.cgh.2013.03.017. Epub 2013 Mar 28.

    PubMed 23542334

  • Soeters PB, Fischer JE. Insulin, glucagon, aminoacid imbalance, and hepatic encephalopathy. Lancet. 1976 Oct 23;2(7991):880-2. doi: 10.1016/s0140-6736(76)90541-9.

    PubMed 62115

  • Vidot H, Carey S, Allman-Farinelli M, Shackel N. Systematic review: the treatment of muscle cramps in patients with cirrhosis. Aliment Pharmacol Ther. 2014 Aug;40(3):221-32. doi: 10.1111/apt.12827. Epub 2014 Jun 18.

    PubMed 24942957

  • 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.

    PubMed 12963433

  • Hidaka H, Nakazawa T, Kutsukake S, Yamazaki Y, Aoki I, Nakano S, Asaba N, Minamino T, Takada J, Tanaka Y, Okuwaki Y, Watanabe M, Shibuya A, Koizumi W. The efficacy of nocturnal administration of branched-chain amino acid granules to improve quality of life in patients with cirrhosis. J Gastroenterol. 2013 Feb;48(2):269-76. doi: 10.1007/s00535-012-0632-x. Epub 2012 Jul 24.

    PubMed 22825550

  • Sobhonslidsuk A, Silpakit C, Kongsakon R, Satitpornkul P, Sripetch C. Chronic liver disease questionnaire: translation and validation in Thais. World J Gastroenterol. 2004 Jul 1;10(13):1954-7. doi: 10.3748/wjg.v10.i13.1954.

    PubMed 15222044

  • Arguedas MR, DeLawrence TG, McGuire BM. Influence of hepatic encephalopathy on health-related quality of life in patients with cirrhosis. Dig Dis Sci. 2003 Aug;48(8):1622-6. doi: 10.1023/a:1024784327783.

    PubMed 12924658

  • 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.

    PubMed 10403745

  • Kawaguchi T, Izumi N, Charlton MR, Sata M. Branched-chain amino acids as pharmacological nutrients in chronic liver disease. Hepatology. 2011 Sep 2;54(3):1063-70. doi: 10.1002/hep.24412. Epub 2011 Jun 23.

    PubMed 21563202

  • 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.

    PubMed 30444744

  • 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.

    PubMed 27467714

  • Nakaya Y, Okita K, Suzuki K, Moriwaki H, Kato A, Miwa Y, Shiraishi K, Okuda H, Onji M, Kanazawa H, Tsubouchi H, Kato S, Kaito M, Watanabe A, Habu D, Ito S, Ishikawa T, Kawamura N, Arakawa Y; Hepatic Nutritional Therapy (HNT) Study Group. BCAA-enriched snack improves nutritional state of cirrhosis. Nutrition. 2007 Feb;23(2):113-20. doi: 10.1016/j.nut.2006.10.008.

    PubMed 17234504

  • Marchesini G, Bianchi G, Merli M, Amodio P, Panella C, Loguercio C, Rossi Fanelli F, Abbiati R; Italian BCAA Study Group. Nutritional supplementation with branched-chain amino acids in advanced cirrhosis: a double-blind, randomized trial. Gastroenterology. 2003 Jun;124(7):1792-801. doi: 10.1016/s0016-5085(03)00323-8.

    PubMed 12806613

  • Muto Y, Sato S, Watanabe A, Moriwaki H, Suzuki K, Kato A, Kato M, Nakamura T, Higuchi K, Nishiguchi S, Kumada H; Long-Term Survival Study Group. Effects of oral branched-chain amino acid granules on event-free survival in patients with liver cirrhosis. Clin Gastroenterol Hepatol. 2005 Jul;3(7):705-13. doi: 10.1016/s1542-3565(05)00017-0.

    PubMed 16206505

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Branched-chain Amino Acid in people with Muscle Cramp and Cirrhosis, run by Mahidol University at 1 site in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of muscle cramp frequency (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05724485, which also lists 23 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2024.

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