Omega-3 fatty acids supplementation for adolescent boys with attention deficit hyperactivity disorder: a double-blind, randomized controlled trial

Completed

• Conditions: Attention deficit hyperactivity disorder (ADHD); Mental and Behavioural Disorders; Attention deficit hyperactivity disorder

• Registration Number: ISRCTN27741572
• Lead Sponsor: King's College London (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05-09
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 60

Inclusion Criteria

1. Male adolescents aged 12-17 years of age from special schools in London and Kent in the UK
2. Subjects who meet ADHD diagnosis criteria using a structured interview (CHIPS) based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria
3. Subjects who have Conners? Parents ADHD Rating Global Scale and Conners? Teachers ADHD Rating Global Scale above 65

Exclusion Criteria

1. Subjects who took omega-3 supplement within 6 months
2. A personal history of diabetes or other metabolic disorder influencing fatty acid metabolism
3. Subjects who are not living in a family home or residential school
4. Subjects who are under special diets (e.g. vegetarian, taking supplements)
5. Subjects who are not in school during the intervention
6. Serious or chronic disease
7. Low blood coagulation function (e.g. haemophilia, hepatic dysfunction, low-vitamin K)
8. Under these medications: alpha tocopherol, selected anticoagulants (aspirin, warfarin, heparin), cyclosporine, clopidogrel, etretinate and topical steroids, cholesterol-lowering medications (atorvastatin, lovastatin, and simvastatin), non-steroidal anti-inflammatory drugs (NSAIDs), dalteparin, dipyrdamole, enoxaparin, ticlopedine
9. Known allergy for fish product derivatives, Vitamin E derivatives, gelatine
10. Abnormal blood data in the baseline assessment
11. All subjects will score higher than 70 on the prorated IQ as measured by The Kaufman Brief Intelligence Test (K-BIT)
12. For the electroencephalogram (EEG) studies only, subjects with left handed, neurological problems or substance abuse will be excluded

Study & Design

• Study Type: Interventional
• Study Design: Not specified