Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000007235
Ethics application status
Approved
Date submitted
11/12/2008
Date registered
7/01/2009
Date last updated
13/12/2018
Date data sharing statement initially provided
13/12/2018
Date results information initially provided
13/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Tyrosine Randomised Controlled Trial in Anorexia Nervosa
Scientific title
In female adolescents with anorexia nervosa, does supplementation with L-tyrosine, when compared with usual treatment alone, lead to improvements in eating disorders psychopathology?
Secondary ID [1] 273413 0
N/A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anorexia Nervosa 4040 0
Condition category
Condition code
Mental Health 4243 4243 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
L-tyrosine approximately 100mg/kg/day administered orally in capsule form for twelve weeks
Intervention code [1] 3760 0
Treatment: Drugs
Comparator / control treatment
Placebo (microcrystalline cellulose) 5g/day administered orally in capsule form for twelve weeks
Control group
Placebo

Outcomes
Primary outcome [1] 5129 0
Eating disorders psychopathology as measured by the Eating Disorders Examination, child version (chEDE)
Timepoint [1] 5129 0
the chEDE will be administered at baseline and week twelve (completion of the study)
Secondary outcome [1] 8632 0
Cognitive function tests (including the Rey Complex Figure, Verbal Fluency, Tower of London, Stroop Test, Verbal Paired Associate Learning, Digit Symbol Coding, Visual Learning, Matching, Trail Making tests and Design Fluency)
Timepoint [1] 8632 0
the cognitive function tests will be administered at baseline and week twelve (completion of the study)

Eligibility
Key inclusion criteria
Female adolescents with anorexia nervosa
Minimum age
12 Years
Maximum age
18 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
males, children (< 12 years) and adults (18 years and over), those with current (or within 6 months) drug or alcohol abuse, use of dietary tyrosine (or other amino acid) supplements within the previous 12 weeks, medically unstable patients, those with concurrent severe medical or neurological illness and participants with Phenylketonuria (inability to convert phenylalanine to tyrosine) and participants requiring noradrenergic or combined noradrenergic medications

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/01/2009
Actual
1/05/2009
Date of last participant enrolment
Anticipated
Actual
30/07/2011
Date of last data collection
Anticipated
Actual
25/10/2011
Sample size
Target
34
Accrual to date
Final
7
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 4286 0
Charities/Societies/Foundations
Name [1] 4286 0
Hunter Medical Research Institute
Country [1] 4286 0
Australia
Primary sponsor type
Individual
Name
Dr Kenneth Nunn
Address
PO Box 611
Neutral Bay NSW 2089
Country
Australia
Secondary sponsor category [1] 3860 0
None
Name [1] 3860 0
Address [1] 3860 0
Country [1] 3860 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6338 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 6338 0
Ethics committee country [1] 6338 0
Australia
Date submitted for ethics approval [1] 6338 0
01/04/2006
Approval date [1] 6338 0
05/06/2006
Ethics approval number [1] 6338 0

Summary
Brief summary
The current study aims to investigate the effectiveness of tyrosine (an amino acid found naturally in protein foods) in the treatment of adolescent females with anorexia nervosa. The design of the study is a double-blind randomized control trial (RCT). The design will allow for the investigation of the effects of tyrosine in the study population, the testing of process measures, and exploration of recruitment and loss to follow up in clinical trials in people with anorexia nervosa.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29175 0
Address 29175 0
Country 29175 0
Phone 29175 0
Fax 29175 0
Email 29175 0
Contact person for public queries
Name 12332 0
Melissa Hart
Address 12332 0
Child and Adolescent Mental Health Service (CAMHS)
621 Hunter St
Newcastle NSW 2300
Country 12332 0
Australia
Phone 12332 0
+61 2 49257800
Fax 12332 0
Email 12332 0
[email protected]
Contact person for scientific queries
Name 3260 0
Dr Kenneth Nunn
Address 3260 0
PO Box 611
Neutral Bay NSW 2089
Country 3260 0
Australia
Phone 3260 0
0425353721
Fax 3260 0
Email 3260 0
[email protected]

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


What supporting documents are/will be available?

No Supporting Document Provided



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.