Randomized Double-blind, Parallel-group Clinical Trial, Placebo Control, to Evaluate the Efficacy and Safety of Docoxahenoic Acid in the Adjuvant Treatment of Children With Autism Spectrum Disorder.
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- ASD
- Sponsor
- Maimónides Biomedical Research Institute of Córdoba
- Enrollment
- 60
- Primary Endpoint
- Plasma and erythrocytic level of DHA
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
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).
Outcomes
Primary Outcomes
Plasma and erythrocytic level of DHA
Time Frame: 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.