Omega-3/6 supplementation for mild to moderate inattentive ADHD: a randomised, double-blind, placebo-controlled efficacy study in Italian children.
| Title: | 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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| Authors: | Carucci, Sara1,2 (AUTHOR) sara.carucci@gmail.com, Romaniello, Roberta1 (AUTHOR), Demuru, Giovanni1 (AUTHOR), Curatolo, Paolo3 (AUTHOR), Grelloni, Clementina3 (AUTHOR), Masi, Gabriele4 (AUTHOR), Liboni, Francesca4 (AUTHOR), Mereu, Alessandra5 (AUTHOR), Contu, Paolo5 (AUTHOR), Lamberti, Marco6,7 (AUTHOR), Gagliano, Antonella1,6,8 (AUTHOR), Zuddas, Alessandro1,2 (AUTHOR) |
| Source: | European Archives of Psychiatry & Clinical Neuroscience. Dec2022, Vol. 272 Issue 8, p1453-1467. 15p. 1 Diagram, 4 Charts, 3 Graphs. |
| Subject Terms: | *YOUTH with attention-deficit hyperactivity disorder, *ITALIANS, *CLINICAL trial laws, *LEARNING disabilities, *LINOLENIC acids, *DOCOSAHEXAENOIC acid |
| 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). [ABSTRACT FROM AUTHOR] |
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