Omega-3/Omega-6 Fatty Acids for Attention-Deficit/Hyperactivity Disorder (ADHD): A Trial in Children and Adolescents
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|ClinicalTrials.gov Identifier: NCT01219309|
Recruitment Status : Completed
First Posted : October 13, 2010
Last Update Posted : October 13, 2010
Objective: To assess whether supplementation with Omega 3/6 fatty acids (eye q®) was effective in the treatment of ADHD and its diagnostic subtypes and comorbid conditions, in children and adolescents.
Method: Randomized placebo-controlled one-way crossover trial with 75 children and adolescents aged 8-18 years receiving Omega 3/6 or placebo for three months followed by 3 months with Omega 3/6 for all. ADHD symptoms were measured with the investigator-rated ADHD Rating Scale-IV-Parent Version and the Clinical Global Impression (CGI) scale of symptom severity and impairment.
|Condition or disease||Intervention/treatment||Phase|
|ADHD Reading/Writing Disorder||Dietary Supplement: Omega 3/6 fatty acids Dietary Supplement: Placebo (olive oil)||Phase 3|
The study design is a randomised, double-blind placebo-controlled trial with a total duration of 6 months. 50-100 children and adolescents, aged 8-18 years, who meet the DSM-IVÔ criteria for Attention-Deficit/Hyperactivity Disorder (ADHD) of any subtype will be given the opportunity to participate. The study comprises 2 study periods.
Study Period I
This is an assessment/evaluation and drug washout phase of up to 1-3 months for those patients taking any medication excluded by the protocol.
Study Period II
Participants will be randomised to 3 months of treatment with a fixed dose of 6 capsules per day of EyeQ, divided in two daily doses, to supply 558 mg EPA, 174 mg DHA and 60 mg GLA daily, or to placebo. Identical capsules containing olive oil will be used as placebo. Randomisation will be organized by Equazen UK Ltd, who will prepare randomisation numbers to be sent out to the investigation centre. At 3 months a one-way treatment crossover of the placebo-group to active treatment will be made so that both patient groups will receive EyeQ for the remaining 3-month period. Compliance will be ascertained through bi-weekly telephone contacts and at each visit. Compliance is defined as taking the prescribed dosage >70% of the days in a visit interval.
DSM IV checklist ADHD-Rating Scale IV - Parent:Inv Clinical Global Impression (CGI) scale GAF-scale
FTF teacher questionnaire SNAP-IV teacher questionnaire Brown's ADD teacher scale
WISC-III® or WAIS-III® VMI Digit span Span-board task Qb-test
Brown's ADD self report CDI (Children's Depression Inventory)
Five to Fifteen (FTF) parent questionnaire Brown's ADD parent scale SNAP-IV parent questionnaire Nijmegen questionnaire HUFA deficiency questionnaire
Reading and writing tests:
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||82 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Omega-3/Omega-6 Fatty Acids for ADHD. A Randomized Placebo-controlled Trial in Children and Adolescents|
|Study Start Date :||August 2004|
|Actual Primary Completion Date :||June 2006|
|Actual Study Completion Date :||April 2007|
|Active Comparator: Omega 3/6 treatment||
Dietary Supplement: Omega 3/6 fatty acids
3 capsules bid orally
Other Name: eyeq
|Placebo Comparator: Placebo||
Dietary Supplement: Placebo (olive oil)
3 capsules bid orally
- ADHD-Rating Scale, Investigator-rated [ Time Frame: From 0-3 months ]The scale comprises the 18 DSM-IV items included in the ADHD diagnosis, and each item is assessed on a 0-3 point scale
- ADHD-Rating Scale, Investigator-rated [ Time Frame: From 3-6 months ]The scale comprises the 18 DSM-IV items included in the ADHD diagnosis, and each item is assessed on a 0-3 point scale
- Clinical Global Impression-Severity Scale [ Time Frame: From 0-3 months ]Investigator-rated global impression of ADHD symptom severity
- Clinical Global Impression-Severity Scale [ Time Frame: From 3-6 months ]Investigator-rated global impression of ADHD symptom severity
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01219309
|Principal Investigator:||Mats Johnson, MD||Göteborg University|