Trial Review

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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
Scientific title
S-Adenosylmethionine (SAM-e) for the treatment of symptoms of fibromyalgia: A double-blind, randomised, placebo controlled trial.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fibromyalgia
Chronic Fatigue Syndrome 2359 0
Condition category
Condition code
Musculoskeletal 2464 2464 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 2078 0
Treatment: Other
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.
Control group
Placebo

Outcomes
Primary outcome [1] 3362 0
Symptom reduction in Fibromyalgia. Specifically we expect a reduction in depressive symptoms, sleep disturbances and gastric disturbances.
Timepoint [1] 3362 0
Measured at three points in time: pre-trial and at 4 and 8 weeks
Secondary outcome [1] 5579 0
Examination of dose-response data and the nature of the placebo effect in these conditions.
Timepoint [1] 5579 0
Measured at three points in time: pre-trial and at 4 and 8 weeks

Eligibility
Key inclusion criteria
Diagnosis of Fibromyalgia by a medical practitioner.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy, Concurrent manic illness.

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)
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.
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
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Double-blinding involves the following: Subjects, Experimenters, Assessors and data analysts.
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 428 0
3127

Funding & Sponsors
Funding source category [1] 2612 0
Commercial sector/Industry
Name [1] 2612 0
Nutrition Care Pharmaceuticals
Country [1] 2612 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
400 Burwood Hwy
Burwood, VICTORIA
Country
Australia
Secondary sponsor category [1] 2361 0
Commercial sector/Industry
Name [1] 2361 0
Nutrition Care Pharmaceuticals
Address [1] 2361 0
25-27 Keysborough Avenue
Keysborough VIC 3173
Country [1] 2361 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4531 0
Deakin University Burwood Campus
Ethics committee address [1] 4531 0
Ethics committee country [1] 4531 0
Australia
Date submitted for ethics approval [1] 4531 0
01/10/2006
Approval date [1] 4531 0
15/11/2006
Ethics approval number [1] 4531 0
EC 158-2006
Ethics committee name [2] 4550 0
Deakin University Burwood Campus
Ethics committee address [2] 4550 0
400 Burwood Hwy
Burwood, 3125
Ethics committee country [2] 4550 0
Australia
Date submitted for ethics approval [2] 4550 0
01/10/2006
Approval date [2] 4550 0
15/11/2006
Ethics approval number [2] 4550 0
EC 158-2006

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28046 0
Address 28046 0
Country 28046 0
Phone 28046 0
Fax 28046 0
Email 28046 0
Contact person for public queries
Name 11203 0
Luke Xantidis
Address 11203 0
Deakin University Burwood Highway Burwood, VIC. 3125
Country 11203 0
Australia
Phone 11203 0
+61 3 5227 8467
Fax 11203 0
Email 11203 0
[email protected]
Contact person for scientific queries
Name 2131 0
DR Gregory Tooley
Address 2131 0
Deakin University Burwood Highway Burwood, VIC. 3125
Country 2131 0
Australia
Phone 2131 0
+61 3 9251 7365
Fax 2131 0
Email 2131 0
[email protected]

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.