Omega-3 Fatty Acids Supplementation in ADHD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2015-05-31

Brief Summary

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The overarching aim of the proposed study is to assess whether omega-3 fatty acids supplementation can augment the effects of methylphenidate in children with ADHD. The investigators hypothesized that omega-3 fatty acids supplementation will be associated with improved ADHD symptoms.

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Detailed Description

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Conditions

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ADHD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Omega-3 Fatty Acids

1g of Omega-3 per day \[400mg DHA \& 600mg EPA\] for 12 weeks: 2 capsules after breakfast and 2 capsules after dinner

Group Type EXPERIMENTAL

Omega-3 Fatty Acids Supplementation

Intervention Type DIETARY_SUPPLEMENT

Omega-3 Placebo

1g of Omega-3 Placebo per day for 12 weeks: 2 capsules after breakfast and 2 capsules after dinner

Group Type PLACEBO_COMPARATOR

Omega-3 Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo capsules manufactured to mimic Omega-3 capsules

Interventions

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Omega-3 Fatty Acids Supplementation

Intervention Type DIETARY_SUPPLEMENT

Omega-3 Placebo

Placebo capsules manufactured to mimic Omega-3 capsules

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

Participants between ages 6 and 12 years who:

1. have been clinically diagnosed with ADHD by a physician
2. meet the criteria of ADHD-Inattention, ADHD-Hyperactivity-Impulsivity, or ADHD-Combined type as determined by the SNAP-IV (Swanson, 1992)
3. are willing to participate in a randomized, double-blind, placebo-controlled trial, complete with written, informed parental consent,
4. are on stable dosage of methylphenidate treatment before the start of the study
5. are able to speak English or German

Exclusion Criteria

1. Participants who are younger than 6 years old or older than 12 years old
2. Those who have not been clinically diagnosed with ADHD by a physician
3. Those who did not meet the criteria of ADHD-Inattention, ADHD-Hyperactivity-Impulsivity, or ADHD-Combined type as determined by the SNAP-IV (Swanson, 1992)
4. Those without written parental consent
5. Those with brain pathology such as serious head injury, epilepsy, and intellectual disability (IQ \< 70)
6. Those with titrated dosage of methylphenidate before the start of the study
7. Those on neurofeedback training, and/or psychosocial intervention addressing attention problems
8. Those with known hypersensitivity to the IMP under investigation
9. Those who are unable to read and understand the parent/participant information
10. Those receiving medications other than methylphenidate

Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No