Omega-3 fatty acids supplementation for adolescent boys with attention deficit hyperactivity disorder: a double-blind, randomized controlled trial
| ISRCTN | ISRCTN27741572 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27741572 |
| Secondary identifying numbers | N/A |
- Submission date
- 10/03/2006
- Registration date
- 09/05/2006
- Last edited
- 20/06/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Dr Eric Taylor
Scientific
Scientific
Child and Adolescent Psychiatry
Institute of Psychiatry
P085 De Crespigny Park
London
SE5 8AF
United Kingdom
| e.taylor@iop.kcl.ac.uk |
Study information
| 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 |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Omega-3 fatty acids supplementation for adolescent boys with attention deficit hyperactivity disorder: a double-blind, randomized controlled trial |
| Study 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 |
| 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 |
Eligibility
| 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 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 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
SE5 8AF
United Kingdom
Sponsor information
King's College London (UK)
University/education
University/education
Institute of Psychiatry
De Crespigny Park
London
SE5 8AF
England
United Kingdom
| g.dale@iop.kcl.ac.uk | |
"ROR" |
https://ror.org/0220mzb33 |
Funders
Funder type
Charity
The Mother and Child Foundation (registered charity number 1037513) (UK)
No information available
Equazen Nutraceutical Ltd. will provide capsules (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2015 | Yes | No |
Editorial Notes
20/06/2016: Publication reference added.
