Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000978066
Ethics application status
Approved
Date submitted
11/11/2010
Date registered
12/11/2010
Date last updated
18/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of a naturally occurring combination of omega-3s on children and adolescents with hyperactivity and inattention
Scientific title
The effects of a naturally occurring combination of omega-3s on children and adolescents with hyperactivity and inattention
Secondary ID [1] 253073 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Symptoms of inattention and hyperactivity 258635 0
Attention Deficit Hyperactivity Disorder 258640 0
Condition category
Condition code
Alternative and Complementary Medicine 257163 257163 0 0
Herbal remedies
Mental Health 258776 258776 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants are randomly allocated to receive one of 2 treatments:
A. Lyprinol (registered trademark) (260mg capsule) 4 capsules daily for 14 Weeks. Lyprinol is a lipid extract of the New Zealand green lipped mussel (Perna canaliculus)
B. Placebo - 4 times daily for 14 weeks

Both treatments should be taken in the morning with food.
Intervention code [1] 257593 0
Behaviour
Intervention code [2] 257597 0
Treatment: Other
Comparator / control treatment
Placebo made of olive oil, identical in appearance and taste to the active treatment, but does not contain any active ingredient.
Control group
Placebo

Outcomes
Primary outcome [1] 259640 0
Level of Inattention and Hyperactivity measured by the Connors Parent Rating Scale
Timepoint [1] 259640 0
Week 2, 4, 8, 10, 14 and 18 after taking their treatment
Secondary outcome [1] 266300 0
Mood (using the Profile of Mood States Questionnaire)
Timepoint [1] 266300 0
Baseline and 2, 4, 8, 10, 14 and 18 weeks after taking their treatment
Secondary outcome [2] 266301 0
Cognitive Function (using the Compass Cognitive test battery which consists of a number of tasks designed to measure memroy, attention and spatial abilities)
Timepoint [2] 266301 0
Baseline and 2, 6, 10 and 14 weeks after taking their treatment
Secondary outcome [3] 266302 0
Steady State Topography (electroencephalography) while doing an attentional cognitive task
Timepoint [3] 266302 0
Baseline and 14 weeks after treatment

Eligibility
Key inclusion criteria
1. Healthy non-smoking males and females aged between 7 and 13 years.
2. DSM-IV ADHD rating score above 15
3. Fluent in English
4. Parent/legal guardian provide a personally signed and dated informed consent indicating that they have been informed of all pertinent aspects of the trial.
5. Participant provide a signed copy of a simplified children’s consent form
Minimum age
6 Years
Maximum age
14 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Medical diagnosis other than ADHD, Oppositional defiance disorder or similar behavioural disorder
2. Currently taking any medication (other than stimulants if a formal diagnosis of ADHD or other behavioural disorder is present)
3. History of / current heart disease or high blood pressure or diabetes
4. Health conditions that would affect food metabolism including the following: food allergies, kidney disease, liver disease and/or gastrointestinal diseases (e.g. Irritable bowel syndrome, coeliac disease, peptic ulcers)
5. Pregnant or breast feeding
6. Unable to participate in all scheduled visits, treatment plan, tests and other trial procedures according to the protocol
7. Allergy to shellfish
8. Epilepsy or photosensitive

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)
Participants will be recruited through advertising in local newspapers and community bulletin boards. Their parents will be screened over the phone to ensure they are able to participate in the study. Participants will be randomly allocated to treatment a or b. Randomization of participants to treatment groups will be determined by random allocation. All participants will be assigned to a treatment using a computerised random number generator. Eligible, recruited participants will be assigned a participant number. The treatment number that has been placed next to the participant’s number will be the allocated treatment order for that individual.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computerised random number generator will determine whether participants are allocated to treatment group a or b. This will be performed by a disinterested third party.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
This is a placebo-controlled, double-blind, parallel groups, randomized trial. Conditions will follow a 2 level (placebo/Lyprinol(registered trademark)) design
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/12/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258040 0
Commercial sector/Industry
Name [1] 258040 0
Pharmalink
Country [1] 258040 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Pharmalink
Address
19 Taree Street
Burleigh Heads
QLD 4220
Country
Australia
Secondary sponsor category [1] 257229 0
None
Name [1] 257229 0
Address [1] 257229 0
Country [1] 257229 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260037 0
Swinburne University Human Research Ethics Committee
Ethics committee address [1] 260037 0
PO Box 218
Hawthorn VIC 3122
Ethics committee country [1] 260037 0
Australia
Date submitted for ethics approval [1] 260037 0
Approval date [1] 260037 0
27/09/2010
Ethics approval number [1] 260037 0
2010/175

Summary
Brief summary
The objective of this trial is to examine whether 14 week administration of lyprinol(registered trademark) improves a range of cognitive, mood, behavioural and psychophysiological measures in children aged 6-14 years with symptoms of inattention and hyperactivity relative to placebo. Children will be enrolled into the study if they have elevated inattention or hyperactivity whether or not they have been diagnosed with Attention Deficit Hyperactivity Disorder (ADHD) and whether or not they are currently medicated for their ADHD. As there is no evidence that Omega 3 intake interferes with current ADHD medications, providing children or adolescents who are currently taking ADHD medication with Lyprinol should be safe and well tolerated (Whitehouse et al, 1997). Their inclusion in the trial will be based on their level of hyperactivity and impulsiveness. If participants are included in the trial and are currently taking stimulant or other medications then this indicates that their current medication is not efficacious, as they are still presenting with high levels of inattention and hyperactivity. We will not include participants who have started stimulant medication for ADHD within the past two weeks as the medication may not have had sufficient time to reach maximum effectiveness. As this is a randomized trial there will be equal probability of the control (placebo) and active (Lyprinol) groups to have the same numbers of participants who are currently on medication. All participants will receive a 14 week supply of Lyprinol(registered trademark) once they finish the study. This is to ensure participants who are allocated to the placebo group also have the opportunity to take the Lyprinol for the same duration as the study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30964 0
Address 30964 0
Country 30964 0
Phone 30964 0
Fax 30964 0
Email 30964 0
Contact person for public queries
Name 14211 0
Prof Con Stough
Address 14211 0
Mail H24, ATC Building, Swinburne University, 427-451 Burwood Road, Hawthorn VIC 3122
Country 14211 0
Australia
Phone 14211 0
+613 9214 8167
Fax 14211 0
Email 14211 0
[email protected]
Contact person for scientific queries
Name 5139 0
Prof Con Stough
Address 5139 0
Mail H24, ATC Building, Swinburne University, 427-451 Burwood Road, Hawthorn VIC 3122
Country 5139 0
Australia
Phone 5139 0
+613 9214 8167
Fax 5139 0
Email 5139 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
SourceTitleYear of PublicationDOI
EmbaseReduced inattention and hyperactivity and improved cognition after marine oil extract (PCSO-524) supplementation in children and adolescents with clinical and subclinical symptoms of attention-deficit hyperactivity disorder (ADHD): a randomised, double-blind, placebo-controlled trial.2017https://dx.doi.org/10.1007/s00213-016-4471-y
Dimensions AIErratum to: A randomized controlled trial investigating the effects of PCSO-524®, a patented oil extract of the New Zealand Green Lipped Mussel (Perna canaliculus), on the behaviour, mood, cognition and neurophysiology of children and adolescents (aged 6–14 years) experiencing clinical and sub-clinical levels of hyperactivity and inattention: study protocol ACTRN126100009780662013https://doi.org/10.1186/1475-2891-12-113
Dimensions AIMarine Mollusks: Food with Benefits2019https://doi.org/10.1111/1541-4337.12429
Dimensions AIAcute supplementation with blackcurrant extracts modulates cognitive functioning and inhibits monoamine oxidase-B in healthy young adults2015https://doi.org/10.1016/j.jff.2015.06.005
N.B. These documents automatically identified may not have been verified by the study sponsor.