Omega-3/6 supplementation for mild to moderate inattentive ADHD: a randomised, double-blind, placebo-controlled efficacy study in Italian children

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Omega-3/6 supplementation for mild to moderate inattentive ADHD: a randomised, double-blind, placebo-controlled efficacy study in Italian children

Carucci et al., 2022 | Eur Arch Psychiatry Clin Neurosci | Rct

Citation

Carucci Sara, Romaniello Roberta, ... Zuddas Alessandro. Omega-3/6 supplementation for mild to moderate inattentive ADHD: a randomised, double-blind, placebo-controlled efficacy study in Italian children. Eur Arch Psychiatry Clin Neurosci. 2022-Dec;272(8):1453-1467. doi:10.1007/s00406-022-01428-2

Abstract

Recently there has been a growing interest in non-pharmacological treatments for ADHD. We evaluated the efficacy of a specific Omega-3/6 dietary supplement (two capsules containing 279 mg eicosapentaenoic acid [EPA], 87 mg Docosahexaenoic Acid [DHA], 30 mg gamma linolenic acid [GLA] each) in ameliorating inattentive symptoms in inattentive-ADHD children (6-12 years) with a baseline ADHD-RS-Inattention score ≥ 12. Secondary objectives included changes in global functioning, severity of illness, depression, and anxiety symptoms, learning disorders and in the fatty acids blood levels. The study was a randomised, double-blind, placebo-controlled efficacy and safety trial with a 6-month double-blind evaluation of Omega-3/6 vs placebo (Phase-I) and a further 6-month-open-label treatment with Omega-3/6 on all patients (Phase-II). In total 160 subjects were enrolled. No superiority of Omega-3/6 supplement to placebo was observed on the primary outcome (ADHD-RS-inattention score) after the first 6-months, with 46.3% of responders in the Omega-3/6 group and 45.6% in the placebo group; a slight (not statistically significant) reduction in Omega-6/3 ratio blood levels was measured in the active treatment group. Twelve months after enrolment, percentages of responders were similar between groups. A mild statistical, although not clinically significant, improvement was observed on the ADHD-RS-total score in the Omega-3/6 group but not on the ADHD-RS-Inattention score; a slight (not-statistically significant) reduction in Omega-6/3 ratio was observed in the group taking active treatment only during Phase II. In conclusion, no clinical beneficial effects of Omega-3/6 were detected on inattentive symptoms, suggesting a limited role of Omega-3/6 dietary products in children with mild ADHD-I.Trial registration: At the time of the Ethical submission, according to the clinical trial Italian law, registration was not mandatory for food additive as Omega 3/6 were then classified. The trial was approved by the Ethical Committee of the Cagliari University Hospital (resolution n. 662; September 22nd, 2011).

Key Findings

662; September 22nd, 2011).

Outcomes Measured

  • anxiety
  • depression

Population

Field Value
Population See abstract
Sample Size 160
Age Range 6-12 years
Condition anxiety

MeSH Terms

  • Child
  • Humans
  • Attention Deficit Disorder with Hyperactivity
  • Fatty Acids, Omega-3
  • Docosahexaenoic Acids
  • Double-Blind Method
  • Dietary Supplements
  • Treatment Outcome

Evidence Classification

  • Level: Rct
  • Publication Types: Randomized Controlled Trial, Clinical Trial, Phase I, Clinical Trial, Phase II, Journal Article
  • Vertical: omega-3-cognition

Provenance

Source extracted via PubMed E-utilities API on 2026-04-09