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TerminatedNCT01777048Updated Jun 24, 2015

Omega-3 Fatty Acids Supplementation in ADHD

A Phase 3 interventional study of Omega-3 Fatty Acids Supplementation and Omega-3 Placebo in ADHD, sponsored by University Hospital, Basel, Switzerland. Terminated at 1 site in Switzerland. Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2015-06-24.

Sponsored by University Hospital, Basel, Switzerland · Phase 3, Interventional, and Treatment

Why this study was terminated
Low recruitment numbers
Phase
Phase 3
Study type
Interventional
Enrollment
8
Allocation
Randomized
Ages
6 Years to 12 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • ADHD
03

In context

Lead sponsor

University Hospital, Basel, Switzerland is the lead sponsor of 968 studies on the registry; 191 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
8 participants (actual)

Study arms

  • Experimental
    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

    Dietary Supplement: Omega-3 Fatty Acids Supplementation

  • Placebo comparator
    Omega-3 Placebo

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

    Dietary Supplement: Omega-3 Placebo

Interventions

  • Dietary supplementOmega-3 Fatty Acids Supplementation
  • Dietary supplementOmega-3 Placebo

    Placebo capsules manufactured to mimic Omega-3 capsules

06

What researchers measure

Primary outcomes

  1. Change in ADHD Rating Scale-IV total score

    Time frame: Baseline, Week 6, and Week 12

Secondary outcomes

  1. Change in Child Behaviour Checklist total score

    Time frame: Baseline and Week 12

07

Study locations

1 site
  • Universitäre Psychiatrische Kliniken (UPK) Basel
    Basel, 4058, Switzerland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01777048
Lead sponsor
University Hospital, Basel, Switzerland
Collaborators
Universitäre Psychiatrische Kliniken (UPK) Basel
Responsible party
Yoon Phaik Ooi (Researcher, University Hospital, Basel, Switzerland) — Principal investigator
First posted
Jan 28, 2013
Start date
Apr 2013
Primary completion
May 2015
Completion
May 2015
Last update
Jun 24, 2015

Study contacts

Yoon Phaik Ooi, PhD
study director · University of Basel

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.

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