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

• Register: ISRCTN
• Last refreshed on: 17 October 2016
• Main ID: ISRCTN27741572
• Date of registration: 09/05/2006
• Prospective Registration: No
• Primary sponsor: King's College London (UK)
• Public title: Omega-3 fatty acids supplementation for adolescent boys with attention deficit hyperactivity disorder: a double-blind, randomized controlled trial
• Scientific title: Omega-3 fatty acids supplementation for adolescent boys with attention deficit hyperactivity disorder: a double-blind, randomized controlled trial
• Date of first enrolment: 20/03/2006
• Target sample size: 60
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN27741572
• Study type: Interventional
• Study design: Double-blind randomised placebo-controlled trial (Treatment)

Countries of recruitment

United Kingdom

Contacts

• Name: Eric Taylor

Key inclusion & exclusion criteria

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

Age minimum:
Age maximum:
Gender: Male

Health Condition(s) or Problem(s) studied

Attention deficit hyperactivity disorder (ADHD)
Mental and Behavioural Disorders
Attention deficit hyperactivity disorder

Intervention(s)

Subjects receiving 6 capsules a day for three months either:
1. 558 mg eicosapentaenoic acid (EPA), 174 mg docosahexaenoic acid (DHA) and 60 mg gamma-linolenic acid (GLA) (per day)
2. 3 g Middle Chain Trygliceride oil with fishy flavour per day (Placebo)

Primary Outcome(s)

Conners? teacher rating scale ADHD index

Secondary Outcome(s)

1. Fatty acids deficiency questionnaire
2. 4-Day dietary patterns questionnaire
3. Buss-Perry aggression scale
4. Strength and difficulty questionnaire
5. Depression Anxiety Stress Scales
6. Barratt impulsivity scale
7. Electroencephalography/event-related potential
8. Blood test (phospholipid fatty acids status in red blood cell and plasma)
9. Conners? parent rating scale
10. Neurophysiological measures

Secondary ID(s)

N/A

Source(s) of Monetary Support

The Mother and Child Foundation (registered charity number 1037513) (UK), Equazen Nutraceutical Ltd. will provide capsules (UK)