Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001037493
Ethics application status
Approved
Date submitted
1/08/2016
Date registered
4/08/2016
Date last updated
23/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Coenzyme Q10 Blood Level Absorption Study in Healthy Adult Volunteers
Scientific title
Coenzyme Q10 Blood Level Absorption Study in Healthy Adult Volunteers
Secondary ID [1] 289781 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
CoQ10 deficiency 299751 0
Condition category
Condition code
Diet and Nutrition 299659 299659 0 0
Other diet and nutrition disorders
Alternative and Complementary Medicine 299684 299684 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of this study is to evaluate the absorption characteristics of a selected group of OVER THE COUNTER (OTC) Coenzyme Q10 PRODUCTS. ONE 100mg preparation will be self administered (orally) each day for SIX consecutive days. All participants will be allocated the same preparation each day, rotating products for six days. Endpoint Classification: Efficacy of Absorption / Safety Trial, Single Group Assignment, Masking; Open Label. Clinical Trial Coordinator to supervise dose administration and any adverse effects.
1) Blackmores 1 capsule=100mg
2) Vitamin Shoppe 1 softgel=100mg
3) Solgar 1 veg capsule=100mg
4) Nature's Way 1 softgel=100mg
5) Jarrow 1 softgel=100mg
6) InMed Technologies LLC 2mL=100mg
Intervention code [1] 295443 0
Treatment: Other
Comparator / control treatment
Coenzyme Q10 preparations (100mg dose) include:
1) Blackmores 1 capsule=100mg
2) Vitamin Shoppe 1 softgel=100mg
3) Solgar 1 veg capsule=100mg
4) Nature's Way 1 softgel=100mg
5) Jarrow 1 softgel=100mg
6) InMed Technologies LLC 2mL=100mg
Control group
Active

Outcomes
Primary outcome [1] 299121 0
Absorption Characteristics assessed in serum levels for each preparation
Timepoint [1] 299121 0
Blood test; blood sampling at baseline (0), 60, 180, 340 minutes post administration of oral dose of OTC (Coenzyme Q10). Absorption Characteristics will be assessed by Serum Tmax of CoQ10
Primary outcome [2] 299148 0
acceptability (of different forms of CoQ10) to participants
Timepoint [2] 299148 0
60, 120, 240, 360 minutes post administration of CoQ10 via semi-structured interview
Secondary outcome [1] 326239 0
Safety - Documentation of any adverse events. Side effects may include: stomach upset, loss of appetite, nausea, vomiting, and diarrhoea. CTC to report participants post administration by direct observation
Timepoint [1] 326239 0
Clinical Trial Coordinator to document any adverse events: subject to participant. Continuous monitoring after dose administered to 6 hours each day.

Eligibility
Key inclusion criteria
1) Participants 18 - 60 years of age at time of entry on study
2) No evidence or documented history of chronic disease
3) Cognitive ability to understand informed consent process and to give informed consent to the experimental treatment
4) Caucasian Ethnicity
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Any clinically abnormal findings which, in the opinion of the investigators / clinicians, may put the participant at risk of adverse events because of participation in the clinical trial including:
1) Previous history of abnormal blood results i.e. FBE, U and E Liver Function Tests and vital signs
2) Use of vitamin or mineral supplements 1 week before the study and or known adverse side effects to supplements
3) Use of pharmaceutical drugs (prescribed or over-the-counter)
4) Female participants who are lactating or pregnant
5) The current use of any nicotine products including
i) nicotine patches/gum ii) tobacco smoking
6) History of alcohol or substance abuse including the use of any illicit drugs
7) Presence of chronic/acute illnesses including hypertension, high cholesterol, diabetes, obesity, irritable bowel syndrome, inflammatory bowel disease, coeliac disease
8) Any psychiatric disorders by history or examination that would prevent completion of the study or result in possible adverse events for the participant (i.e. suicide thoughts or euthanasia requests)
9) Vegetarianism

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Could not procure 2 of the CoQ10 formulations proposed in the protocol.
Date of first participant enrolment
Anticipated
6/02/2017
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 294192 0
Commercial sector/Industry
Name [1] 294192 0
Medlab Clinical
Country [1] 294192 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Medlab Clinical
Address
66 McCauley Street, Alexandria, New South Wales 2015
Country
Australia
Secondary sponsor category [1] 293017 0
None
Name [1] 293017 0
Address [1] 293017 0
Country [1] 293017 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295596 0
National Institute of Integrative Medicine
Ethics committee address [1] 295596 0
11-23 Burwood Road, Hawthorn, Melbourne, VIC 3122
Ethics committee country [1] 295596 0
Australia
Date submitted for ethics approval [1] 295596 0
Approval date [1] 295596 0
22/05/2014
Ethics approval number [1] 295596 0
00252

Summary
Brief summary
To Evaluate the Absorption Efficacy Characteristics and Further Safety Over a 6-hour period of Coenzyme Q10 [100 mg administered as ONE dose orally] from SIX study Preparations to Healthy Participants. The study aims to find out whether;
1) Different Over The Counter (OTC) Coenzyme Q10 products absorb differently as assessed by blood serum levels
2) Different modes of Coenzyme Q10 oral preparations [i.e. as a liquid or capsule] can provide the best delivery vechile
3) and what forms of Coenzyme Q10 such as liquids, capsules or other forms are acceptable to participants
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67702 0
Prof Luis Vitetta
Address 67702 0
Medlab Clinical. 66 McCauley Street, Alexandria, NSW 2015
Country 67702 0
Australia
Phone 67702 0
+61 (2) 8188 0311
Fax 67702 0
Email 67702 0
[email protected]
Contact person for public queries
Name 67703 0
Miss Tessa Nikov
Address 67703 0
Medlab Clinical. 66 McCauley Street, Alexandria, NSW 2015
Country 67703 0
Australia
Phone 67703 0
+61 (2) 8188 0311
Fax 67703 0
Email 67703 0
[email protected]
Contact person for scientific queries
Name 67704 0
Prof Luis Vitetta
Address 67704 0
Medlab Clinical. 66 McCauley Street, Alexandria. NSW 2015
Country 67704 0
Australia
Phone 67704 0
+61 (2) 8188 0311
Fax 67704 0
Email 67704 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.