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Omega-3 Fatty Acids Supplementation for Adolescent Boys with Attention Deficit Hyperactivity Disorder : a double-blind, randomized controlled trial - MAAFA

Omega-3 Fatty Acids Supplementation for Adolescent Boys with Attention Deficit Hyperactivity Disorder : a double-blind, randomized controlled trial - MAAFA

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-005330-12-GB
Enrollment
60
Registered
2006-04-10
Start date
2006-05-11
Completion date
Unknown
Last updated
2018-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention deficit / hyperactivity disorder (ADHD) is defined by DSM-IV criteria, which shows inattention, hyperactivity and impulsivity. ADHD is one of the most common child psychiatric disorders, more likely to be seen in males, and the prevalence is estimated approximately 5% in the UK (NICE ADHD guideline). ADHD is often prominent in early childhood and persist through adolescence to adulthood.

Interventions

Product Name: Eye Q Pharmaceutical Form: Capsule, soft Pharmaceutical form of the placebo: Capsule, soft Route of administration of the placebo: Oral use

Sponsors

King's College London (IOP)
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: Male adolescents aged 12-17 with 1)Both Conners’ Parents ADHD Rating Global Score and Conners' Teachers Rating Global Score are above 65 2)Meet ADHD criteria using a semi-structured interview (CHIPS; Weller, 2000) based on DSM-IV criteria. All subjects will score higher than 70 on the prorated IQ as measured by The Kaufman Brief Intelligence Test (K-BIT) (Chin, 2001). Only right handed males will be tested EEG Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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 whose IQ is less than 70 4) Subjects who are not living in a family home or residential school 5) Subjects who are not in school during the intervention 6) Subjects who are non-English speakers 7) Serious or chronic disease 8) Low blood coagulation function (e.g. haemophilia, hepatic dysfunction, low-vitamin K) 9) Under these Medication: 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, other nutritional supplements. 10) Known allergy for fish product derivatives, Vitamin E derivatives, gelatine, olive oil 11) Pancreatic insufficiency 12) abnormal blood data: Triglyceride For the EEG studies only, subjects with left handed, neurological problems or substance abuse will be excluded.

Design outcomes

Primary

MeasureTime frame
Main Objective: ADHD symptoms are often carried through to the adolescent period and long-term intervention is often needed. Patients and their parents often choose alternative treatments for ADHD. Omega-3 fatty acids supplementation is one popular alternative treatment, and relatively safe, but the effectiveness has not been assessed enough . This study aims to evaluate whether EFA supplementation improves ADHD symptoms in ADHD male adolescents. ;Secondary Objective: In addition, these secondary questions are to be assessed: Does a fatty acids deficiency symptoms score correlate with blood phospholipid levels of essential fatty acids and the symptoms of hyperactivity disorder? Is there any relationship between electroencephalography, ADHD symptoms and fatty acids status? ;Primary end point(s): •Omega-3 fatty acids supplementation improves Conners’ teacher rating scale ADHD global score in ADHD male adolescents. •Omega-3 fatty acids supplementation improves Conners’ parent rating scale ADHD global score in ADHD male adolescents.

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026