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Symptom-specific Effects of Omega-3 Across Neurodevelopmental Symptoms

NCT06698588 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-11-21

No results posted yet for this study

Summary

Our study aims to determine whether omega-3 fatty acid supplementation can improve sleep, mood, and behavior in children with sleep problems and symptoms of Autism Spectrum Disorder (ASD), Attention-Deficit/Hyperactivity Disorder (ADHD), or both. By using a transdiagnostic approach-focusing on specific symptoms rather than diagnostic labels-we aim to identify which children may benefit most from omega-3 supplementation, thereby enhancing inclusivity. Many previous studies have excluded children with both ASD and ADHD, or those without a formal diagnosis.

Conditions

  • Sleep
  • Autism or Autistic Traits
  • ADHD or ADHD Traits

Interventions

DIETARY_SUPPLEMENT

Omega 3 Fish Oil supplements

Wileys Easy Swallow Mini Softgel capsules, dose 3 caps/day, providing 945mg/day long-chain omega-3 (540mg EPA, 405mg DHA).

DIETARY_SUPPLEMENT

Placebo

Placebo: high-oleic sunflower oil (which broadly matches the overall fatty acid composition of typical UK diet), matched with active treatment for appearance and taste.

Sponsors & Collaborators

  • Swansea University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-07
Primary Completion
2025-06-01
Completion
2025-12-01

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06698588 on ClinicalTrials.gov