Condition category
Mental and Behavioural Disorders
Date applied
10/03/2006
Date assigned
09/05/2006
Last edited
20/06/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

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 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

Not provided at time of registration

Study design

Double-blind randomised placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial 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

Phase

Drug names

Primary outcome measures

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 trial start date

20/03/2006

Overall trial end date

30/09/2007

Reason abandoned

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

Patient

Age group

Child

Gender

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

United Kingdom

Trial 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
United Kingdom
-
g.dale@iop.kcl.ac.uk

Sponsor type

University/education

Website

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26682998

Publication citations

Additional files

Editorial Notes

20/06/2016: Publication reference added.