None listed
Conditions
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.
Interventions
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.
Sponsors
Pharmalink
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
6 Years to 14 Years
Healthy volunteers
Yes
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
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
Outcome results
None listed