Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000846921
Ethics application status
Approved
Date submitted
23/07/2020
Date registered
27/08/2020
Date last updated
2/03/2022
Date data sharing statement initially provided
27/08/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of Palmitoylethanolamide (PEA) compared to a placebo on symptoms for upper
respiratory tract infection (URTI) in an Adult Population – A double blind, randomised controlled
trial.
Scientific title
Effect of Palmitoylethanolamide (PEA) compared to a placebo on symptoms for upper
respiratory tract infection (URTI) in an Adult Population – A double blind, randomised controlled
trial.
Secondary ID [1] 301861 0
nil known
Universal Trial Number (UTN)
Trial acronym
PEARTI-20
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Upper Respiratory Tract Infection (URTI) 318358 0
Condition category
Condition code
Alternative and Complementary Medicine 316369 316369 0 0
Other alternative and complementary medicine
Respiratory 316686 316686 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
PEA is a TGA approved ingredient for use in listed medicines in Australia (Brand name Levagen+).

Palmitoylethanolamide (PEA) as Levagen+ will be taken as 2 x 300 mg capsules per day – 1 capsule in the morning, 1 capsule in the evening for the duration of the intervention period (3 months).

During the 3-month study period, participants will be asked to complete a SF-8 questionnaire every 4-weeks. Additionally, if a participant experiences the onset of URTI symptoms (e.g. cough, sneezing, stuffy or runny nose, fever, scratchy or sore throat and nasal breathing), participants will then be required to record their daily symptoms (including the severity) online using the WURSS-24 questionnaire for the duration of the event or up to 2-weeks. Participants are required to continue taking their study product while they are experiencing symptoms. If a participant’s symptoms continue for more than 2-weeks, they will be asked to stop recording the event and seek medical advice (GP). Once symptoms of an event have subsided, participants are asked to continue to take the trial product for the remaining duration of the study period (up to 3-months total) and record any subsequent URTI episodes.

Adherence will be monitored by return and logging of any remaining study product at completion of intervention period.

Intervention code [1] 318155 0
Treatment: Drugs
Comparator / control treatment
The placebo will be dosed in identical capsules as PEA using maltodextrin and microcrystalline cellulose mix and will be taken as 2 capsules per day – 1 capsule in the morning, 1 capsule in the evening, identical to PEA regime, for the duration of the intervention period (3 months).
Control group
Placebo

Outcomes
Primary outcome [1] 324530 0
Upper respiratory tract infection (URTI) incidence via submission of symptomatic
Wisconsin Upper Respiratory Symptom Survey (WURSS-24)
Timepoint [1] 324530 0
Month 3
Secondary outcome [1] 384899 0
URTI duration via submission of symptomatic WURSS-24
Timepoint [1] 384899 0
Baseline, daily from day 2-14 of cold or flu episode.
Secondary outcome [2] 384900 0
Change in URTI severity via WURSS-24
Timepoint [2] 384900 0
Baseline, daily from day 2-14 of cold or flu episode.
Secondary outcome [3] 384901 0
Change in general health via sf-8 questionnaire
Timepoint [3] 384901 0
Baseline, Month 1, Month 2 and Month 3.
Secondary outcome [4] 384902 0
Product tolerance/adverse events (e.g. Gastrointestinal upset, however there are currently no reported adverse events to PEA on the Therapeutic Goods Administration (TGA) register) to be assessed via SF-8 questionnaires every 4 weeks as well as adverse events either spontaneously reported by the participant, or noticed by an investigator.
Timepoint [4] 384902 0
Baseline, Month 1, Month 2 and Month 3 or when spontaneously reported by the participant.
Secondary outcome [5] 384903 0
Days off work via WURSS-24 questionnaire
Timepoint [5] 384903 0
Baseline, daily from day 2-14 of cold or flu episode.

Eligibility
Key inclusion criteria
- Male and females aged 18-65 years old
- Able to provide informed consent
- Agree not to take other supplements (e.g. Echinacea, Vitamin C, zinc) or medications (e.g. Tamiflu, Relenza) aimed at preventing URTIs for the duration of the trial (3 months).
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Unstable or serious illness (e.g. kidney, liver, GIT, heart conditions, diabetes, thyroid gland function, Malignancy, lung conditions or chronic asthma)*
- Acute sickness experienced in the past 2 months
- Serious mood disorders or neurological disorders such as MS
- Active smokers and/or nicotine or drug abuse
- Chronic alcohol use (>14 alcoholic drinks week)
- Allergic to any of the ingredients in active or placebo formula
- Pregnant or lactating woman
- People medically prescribed medications that would affect the immune and/or the inflammatory response.
- Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion
- Participants who have participated in any other related clinical study during the past 1 month
- People with cognitive damage
- People who have or have had treatment for cancer, HIV or chronic use of any dose of steroids (cream, tablet or inhalant) in the past year

*An unstable illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity. A serious illness is a condition that carries a risk of mortality, negatively impacts quality of life and daily function and/or is burdensome in symptoms and/or treatments.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
20/07/2020
Date of last participant enrolment
Anticipated
20/07/2021
Actual
10/11/2021
Date of last data collection
Anticipated
20/07/2021
Actual
15/02/2022
Sample size
Target
300
Accrual to date
Final
428
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 306283 0
Commercial sector/Industry
Name [1] 306283 0
Gencor Pacific
Country [1] 306283 0
Hong Kong
Primary sponsor type
Commercial sector/Industry
Name
RDC Global Pty Ltd
Address
3B/76 Doggett Street
Newstead QLD 4006
Country
Australia
Secondary sponsor category [1] 306775 0
Commercial sector/Industry
Name [1] 306775 0
Gencor Pacific
Address [1] 306775 0
21-E,Elegance
Hillgrove Village
Discovery Bay 999077
Hong Kong
Country [1] 306775 0
Hong Kong
Secondary sponsor category [2] 306778 0
Commercial sector/Industry
Name [2] 306778 0
Pharmako Biotechnologies Pty Ltd
Address [2] 306778 0
36 Campbell Ave, Cromer NSW 2099
Country [2] 306778 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306499 0
Bellberry Limited
Ethics committee address [1] 306499 0
129 Glen Osmond Road
Eastwood South Australia 5063
Ethics committee country [1] 306499 0
Australia
Date submitted for ethics approval [1] 306499 0
Approval date [1] 306499 0
03/07/2020
Ethics approval number [1] 306499 0

Summary
Brief summary
Effect of Palmitoylethanolamide (PEA) compared to a placebo on symptoms for upper
respiratory tract infection (URTI) in an Adult Population – A double blind, randomised controlled
trial.

The aim of this study is to assess the effectiveness of PEA for reducing incidence and severity of URTI symptoms compared to a placebo in otherwise healthy adults aged 18-65 years old.
Trial website
Trial related presentations / publications
Public notes
This study is assessing the effectiveness of PEA to prevent symptoms of the common cold and seasonal flu. It not intended to offer protection from or treatment for COVID-19.

Contacts
Principal investigator
Name 104078 0
Dr David Briskey
Address 104078 0
RDC Global Pty Ltd
3B/76 Doggett Street
Newstead QLD 4006
Country 104078 0
Australia
Phone 104078 0
+61 421 784 077
Fax 104078 0
Email 104078 0
[email protected]
Contact person for public queries
Name 104079 0
Amanda Rao
Address 104079 0
RDC Global Pty Ltd
3B/76 Doggett Street
Newstead QLD 4006
Country 104079 0
Australia
Phone 104079 0
+61 414 488 559
Fax 104079 0
Email 104079 0
[email protected]
Contact person for scientific queries
Name 104080 0
Amanda Rao
Address 104080 0
RDC Global Pty Ltd
3B/76 Doggett Street
Newstead QLD 4006
Country 104080 0
Australia
Phone 104080 0
+61 414 488 559
Fax 104080 0
Email 104080 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No IPD will be shared


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
SourceTitleYear of PublicationDOI
EmbaseThe Efficacy of Palmitoylethanolamide (Levagen+) on the Incidence and Symptoms of Upper Respiratory Tract Infection-A Double Blind, Randomised, Placebo-Controlled Trial.2023https://dx.doi.org/10.3390/nu15204453
N.B. These documents automatically identified may not have been verified by the study sponsor.