Contact information
Type
Scientific
Contact name
Dr Eric Taylor
ORCID ID
Contact details
Child and Adolescent Psychiatry
Institute of Psychiatry
P085 De Crespigny Park
London
SE5 8AF
United Kingdom
-
e.taylor@iop.kcl.ac.uk
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Omega-3 fatty acids supplementation for adolescent boys with attention deficit hyperactivity disorder: a double-blind, randomized controlled trial
Acronym
MAAFA
Study hypothesis
Omega-3 fatty acids supplementation for 3 months is effective and safe to improve symptoms of attention deficit hyperactivity disorder in male adolescents.
Ethics approval(s)
Not provided at time of registration
Study design
Double-blind randomised placebo-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Not specified
Study type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Attention deficit hyperactivity disorder (ADHD)
Intervention
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)
Intervention type
Supplement
Primary outcome measure
Conners teacher rating scale ADHD index
Secondary outcome measures
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
Overall study start date
20/03/2006
Overall study end date
30/09/2007
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type(s)
Patient
Age group
Child
Lower age limit
12 Years
Upper age limit
17 Years
Sex
Male
Target number of participants
60
Participant 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
Recruitment start date
20/03/2006
Recruitment end date
30/09/2007
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
Institute of Psychiatry
London
SE5 8AF
United Kingdom
Sponsor information
Organisation
King's College London (UK)
Sponsor details
Institute of Psychiatry
De Crespigny Park
London
SE5 8AF
England
United Kingdom
-
g.dale@iop.kcl.ac.uk
Sponsor type
University/education
Website
ROR
Funders
Funder type
Charity
Funder name
The Mother and Child Foundation (registered charity number 1037513) (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Equazen Nutraceutical Ltd. will provide capsules (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2015 | Yes | No |