Omega-3 Fatty Acids Supplementation in ADHD

University Hospital Basel

Status and phase: Terminated; Phase 3

Conditions: ADHD

Treatments: Dietary Supplement: Omega-3 Fatty Acids Supplementation; Dietary Supplement: Omega-3 Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01777048

203/12

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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8 participants in 2 patient groups, including a placebo group

Omega-3 Fatty Acids

Experimental group

Description:

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

Treatment:

Dietary Supplement: Omega-3 Fatty Acids Supplementation

Omega-3 Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Omega-3 Placebo