Oral Supplementation with Taurine for Patients with Cirrhosis and Muscle Cramps

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000289819

Enrollment

Registered

2012-03-12

Start date

2012-06-16

Completion date

2015-12-31

Last updated

2021-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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

Interventions

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

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Healthy volunteers

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

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

Outcome results