RecruitingACTRN12610000978066

The effects of a naturally occurring combination of omega-3s on children and adolescents with hyperactivity and inattention


Sponsor

Pharmalink

Enrollment

160 participants

Start Date

Dec 1, 2010

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 6 YearssMax Age: 14 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing whether a natural omega-3 supplement called Lyprinol — derived from green-lipped mussels — can improve attention, behavior, and mood in children aged 6–14 who have symptoms of hyperactivity or inattention (including those with ADHD). Children will take either Lyprinol or a dummy capsule for 14 weeks, and their thinking, behavior, and mood will be tested at the start and end of the study. You may be eligible if: - Your child is between 6 and 14 years old (some sources say 7–13) - Your child is generally healthy and does not smoke - Your child has elevated inattention or hyperactivity symptoms (ADHD rating score above 15) - Your child speaks English fluently - You (the parent or guardian) and your child agree to participate and sign consent forms You may NOT be eligible if: - Your child has a medical diagnosis other than ADHD or a similar behavioral condition - Your child has heart disease, high blood pressure, or diabetes - Your child has kidney, liver, or gut disease, or a food allergy - Your child has epilepsy or is photosensitive - Your child is allergic to shellfish - Your child is pregnant or breastfeeding Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 gr

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.


Locations(1)

Australia

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ACTRN12610000978066


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