Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000377437
Ethics application status
Approved
Date submitted
16/07/2007
Date registered
17/07/2007
Date last updated
17/07/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
The use of a natural medicine, S-adenolsylmethionine (SAM-e) in the treatment of Fibromyalgia and Chronic Fatigue Syndrome
Scientific title
S-Adenosylmethionine (SAM-e) for the treatment of symptoms of fibromyalgia and chronic fatigue syndrome: 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 1957 0
Chronic Fatigue Syndrome 1958 0
Condition category
Condition code
Musculoskeletal 2054 2054 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 two treatment conditions). The SAM-e condition receive capsules containing SAM-e 400mg or 800 mg. Subjects will be required to take the capsules (x2) daily in the morning throughout the trial. Each treatment condition is of 8 weeks duration. All individuals will be exposed to all treatment conditions in this repeated measures design of 24 weeks duration in total.
Intervention code [1] 1890 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 capsules (x2) daily in the morning throughout the trial. Treatment condition is of 8 weeks duration. All individuals will be exposed to all treatment conditions in this repeated measures design of 24 weeks duration in total.
Control group
Placebo

Outcomes
Primary outcome [1] 2881 0
Symptom reduction in both Fibromyalgia and Chronic Fatigue Syndrome. Specifically we expect a reduction in depressive symptoms, sleep disturbances and gastric disturbances.
Timepoint [1] 2881 0
Measured at four points in time: pre-trial and at 8, 16 and 24 weeks.
Secondary outcome [1] 4862 0
Examination of dose-response data and the nature of the placebo effect in these conditions.
Timepoint [1] 4862 0
Measured at four points in time: pre-trial and at 8, 16 and 24 weeks.

Eligibility
Key inclusion criteria
Diagnosis of Fibromyalgia by a medical practitioner.Diagnosis of Chronic Fatigue Syndrome 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. This random allocation is achieved by using a 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 involes the following: Subjects, Experimenters, Assessors and data analysts.
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/09/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 2198 0
Commercial sector/Industry
Name [1] 2198 0
Nutrition Care Pharmaceuticals
Country [1] 2198 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Country
Australia
Secondary sponsor category [1] 1985 0
Commercial sector/Industry
Name [1] 1985 0
Nutrition Care Pharmaceuticals
Address [1] 1985 0
Country [1] 1985 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3995 0
Deakin University Burwood Campus
Ethics committee address [1] 3995 0
Ethics committee country [1] 3995 0
Australia
Date submitted for ethics approval [1] 3995 0
Approval date [1] 3995 0
04/06/2007
Ethics approval number [1] 3995 0
EC 109-2007
Ethics committee name [2] 3996 0
Deakin University Waterfront Campus - Geelong
Ethics committee address [2] 3996 0
Ethics committee country [2] 3996 0
Australia
Date submitted for ethics approval [2] 3996 0
Approval date [2] 3996 0
04/06/2007
Ethics approval number [2] 3996 0
EC 109-2007

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) and chronic fatigue syndrome (CFS).

We have previously conducted a trial with FMS patients using a low dose of SAM-e over a brief timeframe. The results of this study were encouraging and revealed the possibility that a circadian mechanism relying upon adequate SAM-e levels in the brain may provide a new avenue for treatment. We seek to investigate this finding in a comprehensive trial of SAM-e and to include patients with CFS.

As such, salient clinical and pathological parameters will be assessed over a 24-week period in 180 patients who will be provided with the supplement (12 weeks) and placebo preparation (12 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 27704 0
Address 27704 0
Country 27704 0
Phone 27704 0
Fax 27704 0
Email 27704 0
Contact person for public queries
Name 11079 0
Luke Xantidis
Address 11079 0
Deakin University
Burwood Highway
Burwood, VIC. 3125
Country 11079 0
Australia
Phone 11079 0
+61 3 5227 8467
Fax 11079 0
Email 11079 0
[email protected]
Contact person for scientific queries
Name 2007 0
DR Gregory Tooley
Address 2007 0
Deakin University
Burwood Highway
Burwood VIC 3125
Country 2007 0
Australia
Phone 2007 0
+61 3 9251 7365
Fax 2007 0
Email 2007 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.