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

NCT03620097 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-08-08

No results posted yet for this study

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.

Conditions

  • ASD

Interventions

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.

Sponsors & Collaborators

  • Maimónides Biomedical Research Institute of Córdoba

    lead OTHER

Principal Investigators

  • María Mercedes Gil Campos, Doctor · Maimónides Biomedical Research Institute of Córdoba

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-21
Primary Completion
2015-12-02
Completion
2015-12-02

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03620097 on ClinicalTrials.gov