ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12612000289819

Ethics application status

Approved

Date submitted

13/02/2012

Date registered

12/03/2012

Date last updated

11/02/2021

Date data sharing statement initially provided

11/02/2021

Date results provided

11/02/2021

Type of registration

Prospectively registered

Titles & IDs

Public title

Oral Supplementation with Taurine for Patients with Cirrhosis and Muscle Cramps

Scientific title

Does Oral Supplementation with Taurine for Patients with Cirrhosis and Muscle Cramps Reduce the Severity and Frequency of Muscle Cramps?

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Hepatic Cirrhosis

Muscle Cramps

Condition category

Condition code

Oral and Gastrointestinal

Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Musculoskeletal

Other muscular and skeletal disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Oral supplementation with 1g taurine taken as 1 x 500mg capsule 2/day for two weeks followed by oral supplementation with 2g taurine for two weeks taken as 2 x 500mg capsules 2/day
Cross over study with a 24 hour washout period at the cross over point

Intervention code [1]

Treatment: Other

Comparator / control treatment

the comparator used in this study is a placebo capsule for taurine taken as 1 x 500mg capsule placebo (rice flour) 2/day for two weeks followed by 2 x 500mg capsules placebo (rice flour) 2/day

Control group

Placebo

Outcomes

Primary outcome [1]

Reduced frequency of muscle cramps to less than once/week. Participants will complete a questionnaire about muscle cramps including their frequency, severity and duration prior to entry into the study at one month after entry (at the cross over) and at 2 months after entry. Participants will also keep a diary of cramps prior to entry into the study , at 1 month after entry (at cross over) and at 2 months after entry

Timepoint [1]

At one month after entry
At two months after entry
At three months after entry

Secondary outcome [1]

Reduced intensity of muscle cramps to less than 10 minutes per occassion of cramping

Participants will complete a questionnaire about muscle cramps including their frequency, severity and duration prior to entry into the study at one month after entry (at the cross over) at 2 months after entry and at 3 months
Participants will also keep a diary of cramps prior to entry into the study , at 1 month after entry (at cross over) at 2 months after entry and at 3 months after entry

Timepoint [1]

Reduced intensity of muscle cramps. Participants will complete a questionnaire about muscle cramps including their frequency, severity and duration prior to entry into the study at one month after entry (at the cross over) and at 2 months after entry. Participants will also keep a diary of cramps prior to entry into the study , at 1 month after entry (at cross over) at 2 months after entry.

Secondary outcome [2]

Increase serum taurine to normal range
Serum levels of taurine will be analysed

Timepoint [2]

At one month after entry At 2 months after entry

Eligibility

Key inclusion criteria

Patients who present to liver clinic with hepatic cirrhosis and who experience muscle cramps more than three times/week
Abstinent from alcohol and intravenous drug use for 3 months prior to entry into study
If on methadone must be on methadone for 12 months or longer and must be dose stable for 3 months prior to entry into study

Minimum age

18 Years

Maximum age

70 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Muscle cramps less than two occasions/week
Abnormal levels potassium, magnesium and phosphate
Unstable diabetes or a blood sugar level > 15mMol at time of assessment for inclusion in the study
Known peripheral neuropathy
Known thyroid disease
Pulmonary hypertension
Known cardiac disease
Current or recent (within 3 months of assessment)intravenous drug use
Methadone use for less than 12 months
Current use of taurine enriched energy drinks

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Participants will be recruited into study from patients who attend liver clinic or who are being assessed for suitability for liver transplantation
Participants will be randomly assigned to either treatment group or intervention group
Randomisation will be carried out with a sealed opaque envelope

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomisation using procedures like coin tossing and dice rolling

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Crossover

Other design features

Phase

Phase 3

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/06/2012

Actual

16/06/2012

Date of last participant enrolment

Anticipated

Actual

31/12/2015

Date of last data collection

Anticipated

Actual

31/03/2016

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Royal Prince Alfred Hospital - Camperdown

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Royal Prince Alfred Hospital

Address [1]

Missenden Road
Camperdown
NSW 2050

Country [1]

Australia

Primary sponsor type

Hospital

Name

Royal Prince Alfred Hospital

Address

Missenden Road
Camperdown
NSW 2050

Country

Australia

Secondary sponsor category [1]

Charities/Societies/Foundations

Name [1]

RPA Transplant Institute

Address [1]

Missenden Road
Camperdown
NSW 2050

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

SLHD (RPAH Zone)

Ethics committee address [1]

Royal Prince Alfred Hospital
Missenden Road
Camperdown 2050
NSW

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

19/01/2012

Ethics approval number [1]

11/RPAH/453

Summary

Brief summary

Patients with cirrhosis frequently experience painful muscle cramps which can affect the hands, legs, feet, neck, back, sides and abdomen. They may last for several hours, often occur at night and may require opiates or presentation to accident and emergency to control the pain.
The available therapies have limited efficacy. This study aims to determine the efficacy of oral taurine supplementation in reducing the frequency and intensity of painful muscle cramps in this group. It is a randomised control, crossover, blinded study where participants will receive either taurine supplements or placebo for a period of one month and then cross over to the other group. Participants will be asked to complete a questionnaire about muscle cramps prior to entering the study, at the cross over (1 month after entry) and at completion of the study. Participants will be asked to keep a diary of cramps prior to entry into the study and for the duration of the study. In addition to the usual blood taken when attending clinic, a small amount of blood will be taken for amino acid analysis, taurine in particular, and TNF and IL-6

Trial website

Trial related presentations / publications

Vidot H, Cvejic E, Carey S, Strasser SI, McCaughan GW, Allman-Farinelli M, Shackel NA. Randomised clinical trial: oral taurine supplementation versus placebo reduces muscle cramps in patients with chronic liver disease. Alimentary Pharmacology and Therapeutics, 2018; 48(7): 704-12. Epub 2018 Aug 23. doi: 10.1111/apt.14950.

Public notes

Contacts

Principal investigator

Name

A/Prof Nicholas Shackel

Address

South Western Sydney Clinical School, University of New South Wales, Goulbourn Street, Liverpool, NSW 2170

Country

Australia

Phone

+61 287383847

Fax

[email protected]

Contact person for public queries

Name

Helen Vidot

Address

Department Nutrition and Dietetics
RPAH
Missenden Road
Camperdown
NSW 2050

Country

Australia

Phone

+61 2 9515 6111; Pager 81393

Fax

+61 2 9515 5047

[email protected]

Contact person for scientific queries

Name

Professor Nicholas Shackel

Address

South Western Sydney Clinical School, University of New South Wales, Goulbourn Street, Liverpool, NSW 2170

Country

Australia

Phone

+61 287383847

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

confidentiality

What supporting documents are/will be available?

Doc. No.	Type	Citation
10578	Study protocol	[email protected]
10579	Informed consent form	[email protected]
10580	Clinical study report	[email protected]
10581	Ethical approval	[email protected]

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically