Evaluate the Efficacy and Safety of DHA in the Adjuvant Treatment of Children With ASD.

Not Applicable

Completed

• Conditions: ASD
• Interventions: Other: Placebo; Dietary Supplement: EuPoly-3 DHA Infant

• Registration Number: NCT03620097
• Lead Sponsor: Maimónides Biomedical Research Institute of Córdoba

Brief 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.

Study Timeline

• Study Start: 2015-01-21
• Primary Completion: 2015-12-02
• Study Completion: 2015-12-02
• Study First Submitted: 2018-07-18
• Status Verified: 2018-08
• Study First Submitted QC: 2018-08-02
• Last Update Submitted: 2018-08-02
• Study First Posted: 2018-08-08
• Last Update Posted: 2018-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Children and girls aged between 2 and 5 years diagnosed with Autism Spectrum Disorder according to the DSM-V criteria and the Observation Scale for the Diagnosis of Autism (ADOS).
• Informed consent signed by one of the parents or legal representative.

Exclusion Criteria

• Children under 2 years old.
• Children diagnosed with ASD over 4 years old.
• Coexistence of another diagnosis associated with autism.
• Patients who are receiving some type of supplement or concomitant medication that does not allow a period of washing.
• Patients diagnosed with other pathologies or with mediation that may affect the study variables (oxidative stress, inflammation, cell adhesion molecules, lipid profile or microbiota).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Arm	Placebo	30 children will take a placebo with similar lipid characteristics
Experimental Arm	EuPoly-3 DHA Infant	30 subjects will receive 800mg of DHA (Dietary Supplement: EuPoly-3 DHA Infant) per day.

Primary Outcome Measures

Name	Time	Method
Plasma and erythrocytic level of DHA	6 months	Plasma and erythrocytic level of DHA in a sample of patients with ASD before and after an intervention of 6 months of treatment with 800 mg / day of DHA compared with another homogeneous group that will receive placebo.