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

Not Applicable

Recruiting

• Conditions: Symptoms of inattention and hyperactivity; Attention Deficit Hyperactivity Disorder; Alternative and Complementary Medicine - Herbal remedies; Mental Health - Studies of normal psychology, cognitive function and behaviour

• Registration Number: ACTRN12610000978066
• Lead Sponsor: Pharmalink

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-11-12
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
evel of Inattention and Hyperactivity measured by the Connors Parent Rating Scale[Week 2, 4, 8, 10, 14 and 18 after taking their treatment]

Secondary Outcome Measures

Name	Time	Method
Mood (using the Profile of Mood States Questionnaire)[Baseline and 2, 4, 8, 10, 14 and 18 weeks after taking their treatment];Cognitive Function (using the Compass Cognitive test battery which consists of a number of tasks designed to measure memroy, attention and spatial abilities)[Baseline and 2, 6, 10 and 14 weeks after taking their treatment];Steady State Topography (electroencephalography) while doing an attentional cognitive task[Baseline and 14 weeks after treatment]