Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12615000752561
Ethics application status
Approved
Date submitted
24/06/2015
Date registered
21/07/2015
Date last updated
21/07/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Vitamin E metabolomics in healthy volunteers
Scientific title
Administration of vitamin E to healthy volunteers in order to monitor its effect on the metabolome
Secondary ID [1] 286969 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metabolism 295430 0
Condition category
Condition code
Metabolic and Endocrine 295683 295683 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Vitamin E food supplement; 400 mg in form of oral capsules once daily for 14 days.
Adherence will be monitored by drug capsules return.
Intervention code [1] 292175 0
Treatment: Drugs
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 295389 0
The metabolomic profile change after fortnight vitamin E food suplement. This is one composite outcome.
Endogenous metabolome will be obtained using ultra-performance liquid chromatography electrospray ionization time-of-flight mass spectrometry and data analyzed using multivariate analysis tools.
Timepoint [1] 295389 0
Baseline, and at 7th and 14th day after vitamin E food suplement.
Secondary outcome [1] 315494 0
Verify the effect of pregnane xenobiotic receptor (PXR) polymorphisms on potential changes in metabolomics induced by vitamin E food suplement. PXR polymorhism will be detected using PCR methods.
Timepoint [1] 315494 0
Blood samples for PXR polymorphisms identification will be taken at baseline.

Eligibility
Key inclusion criteria
Healthy adult volunteers, aged 18-65 years, of both sexes will be admitted to the study
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Oral Contraception, pregnancy and/or positive pregnancy test, lactation, participation in other clinical trials currently and/or in the previous 3 months, use of drugs with enzyme-inducing properties during the previous 4 weeks, use of vitamin medicinal products (including OTC) in the previous 4 weeks, active viral infection during the previous 4 weeks, immunization during the previous 4 weeks, alcohol and/or drug abuse history, smoking

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
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
29/06/2015
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment outside Australia
Country [1] 6997 0
Czech Republic
State/province [1] 6997 0
Prague

Funding & Sponsors
Funding source category [1] 291526 0
University
Name [1] 291526 0
Charles University in Prague
Country [1] 291526 0
Czech Republic
Primary sponsor type
University
Name
Charles University in Prague
Address
Ovocny trh 3-5

Prague

116 36
Country
Czech Republic
Secondary sponsor category [1] 290207 0
None
Name [1] 290207 0
Address [1] 290207 0
Country [1] 290207 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Objective of this study is to describe the effect of vitamin E food suplement on metabolome in healthy volunteers.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 58338 0
Dr Ondrej Slanar
Address 58338 0
Department of Pharmacology, First Faculty of Medicine, Charles University in Prague and General University Hospital in Prague,
Albertov 4, 128 00 Prague, Czech Republic
Country 58338 0
Czech Republic
Phone 58338 0
+420 224 964 135
Fax 58338 0
Email 58338 0
[email protected]
Contact person for public queries
Name 58339 0
Dr Martin Sima
Address 58339 0
Department of Pharmacology, First Faculty of Medicine, Charles University in Prague and General University Hospital in Prague,
Albertov 4, 128 00 Prague, Czech Republic
Country 58339 0
Czech Republic
Phone 58339 0
+420 224 964 135
Fax 58339 0
Email 58339 0
[email protected]
Contact person for scientific queries
Name 58340 0
Dr Martin Sima
Address 58340 0
Department of Pharmacology, First Faculty of Medicine, Charles University in Prague and General University Hospital in Prague,
Albertov 4, 128 00 Prague, Czech Republic
Country 58340 0
Czech Republic
Phone 58340 0
+420 224 964 135
Fax 58340 0
Email 58340 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.