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Trial registered on ANZCTR
Registration number
ACTRN12607000485437
Ethics application status
Approved
Date submitted
11/09/2007
Date registered
21/09/2007
Date last updated
21/09/2007
Type of registration
Retrospectively registered
Titles & IDs
Public title
The use of a natural medicine, S-adenolsylmethionine (SAM-e) in the treatment of Fibromyalgia
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Scientific title
S-Adenosylmethionine (SAM-e) for the treatment of symptoms of fibromyalgia: A double-blind, randomised, placebo controlled trial.
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Fibromyalgia
Chronic Fatigue Syndrome
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Condition category
Condition code
Musculoskeletal
2464
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0
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Patients will be randomly allocated into groups to commence the trial (placebo and treatment condition). The SAM-e condition receive capsules containing SAM-e 400mg. Subjects will be required to take the capsule daily in the morning throughout the trial. Each treatment condition is of 8 weeks duration. This repeated measures design is of 8 weeks duration in total.
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Intervention code [1]
2078
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Treatment: Other
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Comparator / control treatment
The placebo condition receive capsules that are of identical appearance but containing no SAM-e. Subjects will be required to take the capsule daily in the morning throughout the trial. Treatment condition is of 8 weeks duration.
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Symptom reduction in Fibromyalgia. Specifically we expect a reduction in depressive symptoms, sleep disturbances and gastric disturbances.
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Assessment method [1]
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Timepoint [1]
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Measured at three points in time: pre-trial and at 4 and 8 weeks
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Secondary outcome [1]
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Examination of dose-response data and the nature of the placebo effect in these conditions.
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Assessment method [1]
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Timepoint [1]
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Measured at three points in time: pre-trial and at 4 and 8 weeks
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Eligibility
Key inclusion criteria
Diagnosis of Fibromyalgia by a medical practitioner.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Pregnancy, Concurrent manic illness.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects were referred by their medical practitioner and attended an information evening where they were enrolled. For each diagnostic category, those who meet the inclusion criteria are then randomly allocated to a starting treatment condition to determine the order of treatments in this trial. Allocation concealment was achieved by using a central randomisation table created by computer software. Both subject and experimenter will be blind to the treatment conditions.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This is a fully randomised repeated measures design.The method of sequence generation is by use of a random table created by computer software
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
Double-blinding involves the following: Subjects, Experimenters, Assessors and data analysts.
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Phase
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/09/2006
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
70
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment postcode(s) [1]
428
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3127
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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Nutrition Care Pharmaceuticals
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Address [1]
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25-27 Keysborough Avenue
Keysborough VIC 3173
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Country [1]
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Australia
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Primary sponsor type
University
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Name
Deakin University
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Address
400 Burwood Hwy
Burwood, VICTORIA
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Country
Australia
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Secondary sponsor category [1]
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Commercial sector/Industry
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Name [1]
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Nutrition Care Pharmaceuticals
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Address [1]
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25-27 Keysborough Avenue
Keysborough VIC 3173
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Country [1]
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Deakin University Burwood Campus
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Ethics committee address [1]
4531
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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01/10/2006
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Approval date [1]
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15/11/2006
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Ethics approval number [1]
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EC 158-2006
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Ethics committee name [2]
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Deakin University Burwood Campus
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Ethics committee address [2]
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400 Burwood Hwy Burwood, 3125
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Ethics committee country [2]
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Australia
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Date submitted for ethics approval [2]
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01/10/2006
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Approval date [2]
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15/11/2006
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Ethics approval number [2]
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EC 158-2006
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Summary
Brief summary
Fundamentally, the trial aims to conduct a gold-standard test of the clinical impact of SAM-e in the treatment of depressed mood and general symptoms of fibromyalgia (FMS) As such, salient clinical and pathological parameters will be assessed over a 16-week period in 70 patients who will be provided with the supplement (8 weeks) and placebo preparation (8 weeks). On the basis of previous literature, it is hypothesised that patients in the active treatment group will experience moderate but significant improvements across the clinical measures, and that these gains will be significantly greater than any reported in the placebo group. All patients will provide informed consent. All procedures will be conducted under medical supervision and the preparation itself is very safe when used in the manner proposed for the trial.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Luke Xantidis
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Address
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Deakin University Burwood Highway Burwood, VIC. 3125
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Country
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Australia
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Phone
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+61 3 5227 8467
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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DR Gregory Tooley
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Address
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Deakin University Burwood Highway Burwood, VIC. 3125
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Country
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Australia
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Phone
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+61 3 9251 7365
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Fax
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Email
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[email protected]
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No information has been provided regarding IPD availability
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.
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