Evaluate the Efficacy and Safety of DHA in the Adjuvant Treatment of Children With ASD.
Condition: ASD
MeSH terms: Autism Spectrum Disorder
Study type: Interventional

Summary: 
      In the etiopathogenesis of autistic spectrum disorder (ASD) several hypotheses have been
      described that include inflammation, metabolic alterations, activation of oxidative stress,
      changes in the intestinal microbiota and in the elimination capacity of heavy metals.
      Adjuvant therapies with omega-3 polyunsaturated fatty acids could modify these alterations.
    

Detailed description: 
      Several hypotheses have been described in the etiopathogenesis and evolution of ASD, among
      which is that there is greater oxidative stress associated with a proinflammatory state, or
      even metabolic alterations after exposure to heavy metals, as well as differences in
      intestinal microbiota. This situation could negatively influence the correct establishment of
      neuronal synapses and their functioning, which have still been poorly investigated,
      especially in children. In this way, an early intervention with nutritional supplements with
      DHA, which could be deficient in autism, could decrease the proinflammatory and oxidative
      stress state, favoring the formation of neuronal synapses as well as their activity. This
      intervention could positively influence to prevent the clinical deterioration associated with
      ASD and it would be of special interest in early childhood since at this stage of
      neurodevelopment there is maximum neuronal plasticity.
    

Intervention name(s): EuPoly-3 DHA Infant; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Children will be selected in the first 18 months of the study, and patients with ASD will be included in the trial consecutively, and will be divided into two parallel groups according to the randomization generated by the SIGESMU® computer program with random assignment 1: 1: 30 subjects will receive 800mg of DHA per day and another 30 children, a placebo with similar lipid characteristics except that it will not have DHA content, and for a period of 6 months, double blind. After 6 months, a clinical evaluation and the same baseline analytical study will be carried out again.; Children will be selected in the first 18 months of the study, and patients with ASD will be included in the trial consecutively, and will be divided into two parallel groups according to the randomization generated by the SIGESMU® computer program with random assignment 1: 1: 30 subjects will receive 800mg of DHA per day and another 30 children, a placebo with similar lipid characteristics except that it will not have DHA content, and for a period of 6 months, double blind. After 6 months, a clinical evaluation and the same baseline analytical study will be carried out again.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The nutritional supplement used will be a product marketed according to the European Union regulation. This supplement (EUPOLY-3® DHA Infant) will be provided by Biosearch SA (Granada, Spain), as well as the placebo, in identical containers labeled with a numeric code. Product code: EUP007. The composition of both will differ only in that the formula with DHA will be fish oil refined and stabilized by the addition of soy lecithin, tocopherols of natural origin and ascorbic palmitate. In addition, its level of toxic in the raw material is controlled. This product, and the placebo, will keep the rest of the fatty acid profile similar (eg content of linoleic and linolenic fatty acids). It will be designed in a formulation suitable for preschool children with ASD; in liquid form and in a concentrated dose to ingest orally in the least amount possible (approximately 1.5cc in each dose).
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Autism Spectrum Disorders; ASD; Children; Autism; Docosahexaenoic acid; Inflammation; Oxidative stress; Intestinal microbiota; heavy metals