ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Symptoms of inattention and hyperactivity

Attention Deficit Hyperactivity Disorder

Condition category

Condition code

Alternative and Complementary Medicine

Herbal remedies

Mental Health

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]

Behaviour

Intervention code [2]

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]

Level of Inattention and Hyperactivity measured by the Connors Parent Rating Scale

Timepoint [1]

Week 2, 4, 8, 10, 14 and 18 after taking their treatment

Secondary outcome [1]

Mood (using the Profile of Mood States Questionnaire)

Timepoint [1]

Baseline and 2, 4, 8, 10, 14 and 18 weeks after taking their treatment

Secondary outcome [2]

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]

Baseline and 2, 6, 10 and 14 weeks after taking their treatment

Secondary outcome [3]

Steady State Topography (electroencephalography) while doing an attentional cognitive task

Timepoint [3]

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]

Commercial sector/Industry

Name [1]

Pharmalink

Address [1]

19 Taree Street
Burleigh Heads
QLD 4220

Country [1]

Australia

Primary sponsor type

Commercial sector/Industry

Name

Pharmalink

Address

19 Taree Street
Burleigh Heads
QLD 4220

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Swinburne University Human Research Ethics Committee

Ethics committee address [1]

PO Box 218
Hawthorn VIC 3122

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

27/09/2010

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Prof Con Stough

Address

Mail H24, ATC Building, Swinburne University, 427-451 Burwood Road, Hawthorn VIC 3122

Country

Australia

Phone

+613 9214 8167

Fax

cstough@swin.edu.au

Contact person for scientific queries

Name

Prof Con Stough

Address

Mail H24, ATC Building, Swinburne University, 427-451 Burwood Road, Hawthorn VIC 3122

Country

Australia

Phone

+613 9214 8167

Fax

cstough@swin.edu.au

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

Source	Title	Year of Publication	DOI
Dimensions AI	Erratum 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 ACTRN12610000978066	2013	https://doi.org/10.1186/1475-2891-12-113
Dimensions AI	Acute supplementation with blackcurrant extracts modulates cognitive functioning and inhibits monoamine oxidase-B in healthy young adults	2015	https://doi.org/10.1016/j.jff.2015.06.005
Embase	Reduced 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.	2017	https://dx.doi.org/10.1007/s00213-016-4471-y
Dimensions AI	Marine Mollusks: Food with Benefits	2019	https://doi.org/10.1111/1541-4337.12429

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

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