Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000420448
Ethics application status
Approved
Date submitted
14/08/2007
Date registered
21/08/2007
Date last updated
21/08/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Effect of the Antioxidant (GliSODin) on Unexplained Fatigue
Scientific title
Evaluation of an orally-bioactive form of Superoxide Dismutase, GliSODin, in reducing levels of fatigue in otherwise healthy women aged between 50-65 years over a 12-week period.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fatigue 2257 0
Condition category
Condition code
Metabolic and Endocrine 2340 2340 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Superoxide dismutase enzyme in an orally-bioactive form, 250mg daily for 12 weeks. The capsule contains 3.11mg melon extract in a base of maltodexrtin.
Intervention code [1] 1993 0
Treatment: Drugs
Comparator / control treatment
Double-blind placebo-controlled, using an identical-looking 2-piece gel capsule containing maltodextrin, the same filler used in the active capsule.
Control group
Placebo

Outcomes
Primary outcome [1] 3244 0
Subjective markers of fatigue
Timepoint [1] 3244 0
12 weeks
Secondary outcome [1] 5396 0
Blood levels of endogenous antioxidant enzymes, Superoxide dismutase (SOD) and Glutathione peroxidase
Timepoint [1] 5396 0
Baseline, 6 weeks and 12 weeks
Secondary outcome [2] 5397 0
To evaluate the effects of the intervention on several biochemical markers of oxidative stress, before during and after 12 weeks of treatment.
Timepoint [2] 5397 0
Baseline, 6 weeks and 12 weeks
Secondary outcome [3] 5398 0
To evaluate the blood levels of stress-related hormones
Timepoint [3] 5398 0
Baseline, 6 weeks, 12 weeks

Eligibility
Key inclusion criteria
Unexplained fatigue of greater than 3 months' duration
Minimum age
50 Years
Maximum age
65 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Clinical Depression, Diagnosed Thyroid Disorder, Iron-deficiency anaemia, Coeliac Disease, Any serious disease, History of Alcohol or Drug Abuse, Primary Sleep Disorder

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)
Randomisation conducted by the Hospital Pharmacy from which the medication is dispensed. Eligibility for participation in the trial was conducted by personnel in Brisbane who will have no contact at any stage of the study with the personnel in Launceston Hospital who randomise the medication. The capsules are dispensed in identical white plastic tablet bottles named for the study and identified only by numbers from 1-40. The code is held by this off-site pharmacy in Launceston.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table from a statistic book
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 378 0
4006

Funding & Sponsors
Funding source category [1] 2504 0
Commercial sector/Industry
Name [1] 2504 0
IsoCell NUTRA
Country [1] 2504 0
France
Funding source category [2] 2505 0
Commercial sector/Industry
Name [2] 2505 0
Applied Science & Nutrition
Country [2] 2505 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Applied Science & Nutrition
Address
34 Kingsholme Street,
New Farm QLD
Country
Australia
Secondary sponsor category [1] 2275 0
Other Collaborative groups
Name [1] 2275 0
Cell-Logic Pty Ltd
Address [1] 2275 0
58 Kingston Drive
Helensvale QLD 4212
Country [1] 2275 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4421 0
University of Queensland
Ethics committee address [1] 4421 0
University of Queensland,
Brisbane QLD 4072
Ethics committee country [1] 4421 0
Australia
Date submitted for ethics approval [1] 4421 0
28/05/2007
Approval date [1] 4421 0
30/05/2007
Ethics approval number [1] 4421 0
HMS07/3005

Summary
Brief summary
Fatigue is a common problem and in many cases its cause cannot be medically explained. An understanding of the biochemical processes humans use to generate energy within the cells leads to a hypothesis to explain the cause of some forms of fatigue based on defective cellular energy processes. The active substance used in this study, GliSODin contains Superoxide Dismutase, an enzyme which may assist in the normal biochemical production of energy in human cells.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27979 0
Address 27979 0
Country 27979 0
Phone 27979 0
Fax 27979 0
Email 27979 0
Contact person for public queries
Name 11136 0
Dr Elizabeth Steels
Address 11136 0
34 Kingsholme Street,
New Farm QLD 4006
Country 11136 0
Australia
Phone 11136 0
07 3254-2812
Fax 11136 0
Email 11136 0
[email protected]
Contact person for scientific queries
Name 2064 0
Christine Houghton
Address 2064 0
12 Blackthorne Street,
Ormiston QLD 4160
Country 2064 0
Australia
Phone 2064 0
07 3488 0385
Fax 2064 0
07 3488 0389
Email 2064 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.