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Trial registered on ANZCTR


Registration number
ACTRN12612000552886
Ethics application status
Approved
Date submitted
23/05/2012
Date registered
24/05/2012
Date last updated
20/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Coenzyme Q10 for Alleviation of the Fatigue of Post Polio Syndrome
Scientific title
Oral supplementation of polio survivors with Post Polio Syndrome or Late Effects of Polio by coenzyme Q10 for relief of their excessive fatigue, as measured by fatigue questionnaires.
Secondary ID [1] 280538 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Excessive fatigue symptom of Post Polio Syndrome/Late Effects of Polio 286536 0
Condition category
Condition code
Neurological 286803 286803 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Oral supplementation by 100 mg capsule of CoQ10 daily for a period of 2 months
Intervention code [1] 284915 0
Treatment: Drugs
Intervention code [2] 284916 0
Rehabilitation
Comparator / control treatment
Placebo of oil capsule which is taken daily for a period of 2 months
Control group
Placebo

Outcomes
Primary outcome [1] 287173 0
A statistically significant reduction in fatigue levels in the CoQ10 intervention group as compared to the placebo group, as assessed by the Fatigue Severity Scale (FSS) and the Multidimensional Assessment of Fatigue (MAF) Scale.
Timepoint [1] 287173 0
Two months after randomisation.
Secondary outcome [1] 297555 0
Nil
Timepoint [1] 297555 0
Nil

Eligibility
Key inclusion criteria
Polio survivors with Post Polio Syndrome or the Late Effects of Polio who attribute their excessive fatigue primarily to PPS/LEOP
Minimum age
50 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Diagnosis with another medical condition that may account for the excessive fatigue, e.g. diabetes, anaemia, thyroid deficiency or fibromyalgia.
Treatment with warfarin since CoQ10 can redcue its effectiveness.
Those already taking CoQ10 on a regular basis

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 will be enrolled into the study and allocated to the intervention and placebo groups by the automated randomisation service of the Griffith Clinical Trials Unit. Those who use energy-saving, motorised wheelchairs or scooters solely or mainly for mobility will be randomly equally distributed to the intervention and placebo groups to prevent bias (stratified randomisation).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
By an automated, random-order, computer-generated program at the Griffith Clinical Trials Unit.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD

Funding & Sponsors
Funding source category [1] 285302 0
Charities/Societies/Foundations
Name [1] 285302 0
Cancer and Polio Research Fund
Address [1] 285302 0
Newell Lane
Hoylake
Wirral CH47 4BQ
Country [1] 285302 0
United Kingdom
Primary sponsor type
Individual
Name
Professor Marie Cooke
Address
School of Nusring and Midwifery
Griffith University
Nathan Campus
Kessels Road
Nathan
QLD 4111
Country
Australia
Secondary sponsor category [1] 284163 0
Individual
Name [1] 284163 0
Professor Wendy Moyle
Address [1] 284163 0
Director, Centre for Clinical and Community Innovation
School of Nursing and Midwifery
Griffith University
Nathan Campus
Kessels Road
Nathan
QLD 4111
Country [1] 284163 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287312 0
Griffith University HREC
Ethics committee address [1] 287312 0
Ethics committee country [1] 287312 0
Australia
Date submitted for ethics approval [1] 287312 0
25/05/2012
Approval date [1] 287312 0
09/07/2012
Ethics approval number [1] 287312 0
NRS/20/12/HREC

Summary
Brief summary
The primary purpose of the clinical trial is to determine whether taking a 100 mg capsule of coenzyme Q10 daily for a period of two months can alleviate the excessive fatigue of Post Polio Syndrome or Late Effects of Polio. This will be tested in a randomised, double-blind, placebo-controlled trial at the Griffith Clinical Trials Unit. Fatigue will be assessed by two fatigue questionnaires to be filled out by the participants before the start of the trial (baseline) and after the two-month period of taking capsules. Coenzyme Q10 blood levels will also be determined to confirm compliance and to validate the findings. Statistical analysis of the questionnaires will be undertaken by a biostatistician.
Trial website
Trial related presentations / publications
Manuscript now accepted
MM Peel, M Cooke, HJ Lewis-Peel, RA Lea, W Moyle (2015). . Investigation of the alleviation of fatigue of the late-onset sequelae of poliomyelitis by coenzyme Q10: a randomised, double-blind, placebo-controlled trial.
Complementary Therapies in Medicine 23 (6), 789-793
http://dx.doi.org/10.1016/j.ctim.2015.09.002
Public notes

Contacts
Principal investigator
Name 34215 0
Dr Margaret Peel
Address 34215 0
C/- Marie Cooke
Griffith University
N48_2.21
170 Kessels Road
Nathan Qld 4111
Country 34215 0
Australia
Phone 34215 0
+61 07 32646783
Fax 34215 0
Email 34215 0
mmp27@aapt.net.au
Contact person for public queries
Name 17462 0
Prof Professor Marie Cooke
Address 17462 0
Professor of Nursing
School of Nursing and Midwifery
Griffith University
Nathan Campus
Kessels Road
Nathan
QLD 4111
Country 17462 0
Australia
Phone 17462 0
+61 7 3735 5253
Fax 17462 0
+61 7 3735 5431
Email 17462 0
m.cooke@griffith.edu.au
Contact person for scientific queries
Name 8390 0
Prof Professor Marie Cooke
Address 8390 0
Professor of Nursing
School of Nursing and Midwifery
Griffith University
Nathan Campus
Kessels Road
Nathan
QLD 4111
Country 8390 0
Australia
Phone 8390 0
+61 7 3735 5253
Fax 8390 0
+61 7 3735 5431
Email 8390 0
m.cooke@griffith.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary