Trial Review

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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 information initially 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] 279925 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatic Cirrhosis 285838 0
Muscle Cramps 285851 0
Condition category
Condition code
Oral and Gastrointestinal 286019 286019 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Musculoskeletal 286029 286029 0 0
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] 284252 0
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] 286507 0
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] 286507 0
At one month after entry
At two months after entry
At three months after entry
Secondary outcome [1] 296042 0
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] 296042 0
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] 296079 0
Increase serum taurine to normal range
Serum levels of taurine will be analysed
Timepoint [2] 296079 0
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?
No
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
50
Accrual to date
Final
49
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 2190 0
Royal Prince Alfred Hospital - Camperdown

Funding & Sponsors
Funding source category [1] 284699 0
Hospital
Name [1] 284699 0
Royal Prince Alfred Hospital
Country [1] 284699 0
Australia
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hospital
Address
Missenden Road
Camperdown
NSW 2050
Country
Australia
Secondary sponsor category [1] 283600 0
Charities/Societies/Foundations
Name [1] 283600 0
RPA Transplant Institute
Address [1] 283600 0
Missenden Road
Camperdown
NSW 2050
Country [1] 283600 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286701 0
SLHD (RPAH Zone)
Ethics committee address [1] 286701 0
Royal Prince Alfred Hospital
Missenden Road
Camperdown 2050
NSW
Ethics committee country [1] 286701 0
Australia
Date submitted for ethics approval [1] 286701 0
Approval date [1] 286701 0
19/01/2012
Ethics approval number [1] 286701 0
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 33767 0
A/Prof Nicholas Shackel
Address 33767 0
South Western Sydney Clinical School, University of New South Wales, Goulbourn Street, Liverpool, NSW 2170
Country 33767 0
Australia
Phone 33767 0
+61 287383847
Fax 33767 0
Email 33767 0
[email protected]
Contact person for public queries
Name 17014 0
Ms Helen Vidot
Address 17014 0
Department Nutrition and Dietetics
RPAH
Missenden Road
Camperdown
NSW 2050
Country 17014 0
Australia
Phone 17014 0
+61 2 9515 6111; Pager 81393
Fax 17014 0
+61 2 9515 5047
Email 17014 0
[email protected]
Contact person for scientific queries
Name 7942 0
Prof Professor Nicholas Shackel
Address 7942 0
South Western Sydney Clinical School, University of New South Wales, Goulbourn Street, Liverpool, NSW 2170
Country 7942 0
Australia
Phone 7942 0
+61 287383847
Fax 7942 0
Email 7942 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
confidentiality


What supporting documents are/will be available?

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



Results publications and other study-related documents

Documents added manually

Documents added automatically
No additional documents have been identified.