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

ASD Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03620097
• Other study ID #: ICI14/00355
• Status: Completed
• Phase: N/A
• Start date: January 21, 2015
• Est. completion date: December 2, 2015

Study information

• Verified date: August 2018
• Source: Maimónides Biomedical Research Institute of Córdoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2, 2015
• Est. primary completion date: December 2, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 5 Years

Eligibility

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).

Related Conditions & MeSH terms

• ASD
• Autism Spectrum Disorder

Intervention

Dietary Supplement:
• EuPoly-3 DHA Infant
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.

Other:
• Placebo
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Maimónides Biomedical Research Institute of Córdoba

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma and erythrocytic level of DHA	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.	6 months