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Trial registered on ANZCTR


Registration number
ACTRN12622000844741
Ethics application status
Approved
Date submitted
15/02/2022
Date registered
15/06/2022
Date last updated
15/06/2022
Date data sharing statement initially provided
15/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the vitamin E from palm oil on immune response to flu vaccine
Scientific title
Immune modulation mechanisms in healthy human volunteers following influenza vaccination and daily supplementation palm tocotrienol-rich fraction
Secondary ID [1] 306436 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Immune response to influenza vaccine healthy volunteers 326546 0
Condition category
Condition code
Inflammatory and Immune System 322673 322673 0 0
Normal development and function of the immune system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Healthy volunteers will be randomly assigned to one of five study groups i.e. daily oral supplementation with tocotrienol-rich fraction (TRF) sofgels [50 mg, 100 mg, 200 mg or 400 mg] for 8 weeks.

All subjects will receive a single intramuscular injection of flu vaccine in their arm at the end of week 4 (Day 28) and will continue with the same supplementation for another 4 weeks. The flu vaccine that we plan to use for this study is the Vaxigrip Tetra Influenza Vaccine Types A &B

All subjects will be asked to bring along the bottles with the supplements as a way of monitoring compliance
Intervention code [1] 322869 0
Treatment: Other
Comparator / control treatment
Data from TRF supplemented groups will be compared with placebo as well as between doses.

Healthy volunteers randomly assigned to a placebo group will receive daily oral supplementation with placebo softgels (contains palm olein) for 8 weeks.

All subjects will receive a single intramuscular injection of flu vaccine in their arm at the end of week 4 (Day 28) and will continue with the same supplementation for another 4 weeks. The flu vaccine that we plan to use for this study is the Vaxigrip Tetra Influenza Vaccine Types A &B

All subjects will be asked to bring along the bottles with the supplements as a way of monitoring compliance
Control group
Placebo

Outcomes
Primary outcome [1] 330467 0
Immune response to the influenza vaccine by quantifying antibodies to influenza vaccine in blood samples using ELISA with or without supplementation with tocotrienol-rich fraction (TRF)
Timepoint [1] 330467 0
This primary outcome will only be determined with samples taken on day 56 post-intervention
Secondary outcome [1] 410558 0
Plasma levels of vitamin E
Timepoint [1] 410558 0
This will be determined with plasma samples taken on day 56 post-intervention using high-performance liquid chromatography (HPLC)

Eligibility
Key inclusion criteria
18-60 years-old
Healthy and free of diseases (biochemical tests)
Do not have any chronic conditions (e.g. metabolic diseases, diabetes, cancer)
Not on any long-term treatment/medication
Not taken any vitamin E supplements for the past 3-months (low plasma vitamin E)
Non-smoker
Not received any flu vaccination in the last 12-months (low antibody to influenza vaccine)
Normal to overweight bodyweight
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Have some health-related problems (e.g. flu, fever, allergy)
Organ failures
Obese
Pregnant (females)
Breast-feeding (females)

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will be performed using the following methods:
1. sealed opaque envelopes
2. numbered containers
3. allocation involved contacting the holder of the allocation schedule who was “off-site” or at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using procedures
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be analysed using Analysis of Variance (ANOVA) with post-hoc Tukey using the SPSS version 24

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2022
Actual
Date of last participant enrolment
Anticipated
31/12/2022
Actual
Date of last data collection
Anticipated
28/02/2023
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment outside Australia
Country [1] 24581 0
Malaysia
State/province [1] 24581 0
Selangor Darul Ehsan

Funding & Sponsors
Funding source category [1] 310783 0
Government body
Name [1] 310783 0
Malaysian Palm Oil Board
Country [1] 310783 0
Malaysia
Funding source category [2] 311084 0
Commercial sector/Industry
Name [2] 311084 0
EXCELVITE SDN. BHD.
Country [2] 311084 0
Malaysia
Funding source category [3] 311085 0
University
Name [3] 311085 0
Monash University Malaysia
Country [3] 311085 0
Malaysia
Funding source category [4] 311086 0
Commercial sector/Industry
Name [4] 311086 0
Hovid Berhad
Country [4] 311086 0
Malaysia
Primary sponsor type
University
Name
Monash University Malaysia
Address

Monash University Malaysia Sdn Bhd
Jalan Lagoon Selatan
Bandar Sunway
47500 Petaling Jaya
Selangor
Malaysia
Country
Malaysia
Secondary sponsor category [1] 312415 0
None
Name [1] 312415 0
Address [1] 312415 0
Country [1] 312415 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310357 0
Monash University Human Research Ethics Committee (MUHREC)
Ethics committee address [1] 310357 0
Ethics committee country [1] 310357 0
Australia
Date submitted for ethics approval [1] 310357 0
08/11/2021
Approval date [1] 310357 0
27/01/2022
Ethics approval number [1] 310357 0
30401

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 117366 0
Prof Ammu K Radhakrishnan
Address 117366 0
Jeffrey Cheah School of Medicine and Health Sciences
Monash University Malaysia
Jalan Lagoon Selatan,
47500 Bandar Sunway,
Selangor Darul Ehsan,
Malaysia
Country 117366 0
Malaysia
Phone 117366 0
+60355144902
Fax 117366 0
Email 117366 0
ammu.radhakrishnan@monash.edu
Contact person for public queries
Name 117367 0
Ammu Kutty Radhakrishnan
Address 117367 0
Jeffrey Cheah School of Medicine and Health Sciences
Monash University Malaysia
Jalan Lagoon Selatan,
47500 Bandar Sunway,
Selangor Darul Ehsan,
Malaysia
Country 117367 0
Malaysia
Phone 117367 0
+60355144902
Fax 117367 0
Email 117367 0
ammu.radhakrishnan@monash.edu
Contact person for scientific queries
Name 117368 0
Ammu Kutty Radhakrishnan
Address 117368 0
Jeffrey Cheah School of Medicine and Health Sciences
Monash University Malaysia
Jalan Lagoon Selatan,
47500 Bandar Sunway,
Selangor Darul Ehsan,
Malaysia
Country 117368 0
Malaysia
Phone 117368 0
+60355144902
Fax 117368 0
Email 117368 0
ammu.radhakrishnan@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified raw data for each participant outside of the investigator team for the purposes of IPD meta-analyses, upon request
When will data be available (start and end dates)?
The IPD data will be available upon request six months from the date that the results from this study have been analysed and published for up to 12-months.
Alternatively, an email can be sent to the principal investigator:
Prof Ammu Radhakrishnan,
Jeffrey Cheah School of Medicine and Health Sciences,
Monash University Malaysia,
Email: ammu.radhakrishnan@monash.edu)
Available to whom?
To researchers who would like to use this data for meta-analysis
Available for what types of analyses?
Meta-analysis
How or where can data be obtained?
The email and contact address of the PI or corresponding author will be available in the published paper
If data is required before publication, an email can be sent to the PI (ammu.radhakrishnan@monash.edu), who can provide information on how this can be obtained.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15104Informed consent form    383577-(Uploaded-15-02-2022-13-50-37)-Study-related document.pdf
15105Ethical approval    383577-(Uploaded-15-02-2022-13-51-26)-Study-related document.pdf



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.