The role of omega-3 supplementation in improving ADHD symptomatology and its consequences in preschoolers: a double-blind, placebo-controlled, randomized clinical trial

Abstract

BACKGROUND: Attention deficit hyperactivity disorder is one of the most common neurodevelopmental disorders in childhood which, in most cases, remains during adolescence and adult life. It is characterised by a persistent pattern of inattention and/or hyperactivity, and impulsivity. This symptomatology is present in many contexts, affecting these children’s daily life. The standard treatment consists of taking a stimulant drug (like methylphenidate) in addition to psychological therapy and a curricular and classroom adaptation. Even though the first symptoms appear during the first years of life, pharmacological treatment can’t be given to children under 6 years old. ADHD medication has many adverse effects and no studies have assessed its long-term safety and effectiveness. That is why there is a growing interest in finding alternatives to traditional treatment, and one of the most popular is Omega-3 supplementation. OBJECTIVES: The aim of this clinical trial is to compare the improvement in ADHD symptomatology and in the impairment that it causes in children who take Omega-3 supplementation in comparison to children taking placebo. DESIGN: A double-blind, placebo-controlled, randomized clinical trial PARTICIPANTS: Preschoolers, understood as children from 4 to 6 years old, who are discharged from a CDIAP with a suspected diagnose of ADHD. Our sample size will be 178 children, 89 in the control group (taking placebo) and 89 in the intervention group (taking Omega-3). METHOD: Preschoolers taking part in the study will be randomly distributed into two groups: one will be taking Omega-3 supplementation and the other one will take placebo. All children will have to take two daily pills in the morning for two years. At the beginning of the study and every 6 months, they will attend a visit to collect their medical history and some measurements (height, weight, blood pressure and heart rate). Moreover, their parents and teachers will answer two questionnaires regarding the degree of symptomatology and impairment