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

NCT03620097 | Completed

• 1 other identifier: ICI14/00355
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

ASD

Keywords

Autism Spectrum Disorders; ASD; Children; Autism; Docosahexaenoic acid; Inflammation; Oxidative stress; Intestinal microbiota; heavy metals

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Experimental Arm

EXPERIMENTAL

30 subjects will receive 800mg of DHA (Dietary Supplement: EuPoly-3 DHA Infant) per day.

Dietary Supplement: EuPoly-3 DHA Infant

Control Arm

PLACEBO COMPARATOR

30 children will take a placebo with similar lipid characteristics

Other: Placebo

Interventions

EuPoly-3 DHA Infant DIETARY_SUPPLEMENT

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.

Experimental Arm

Placebo OTHER

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.

Control Arm

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Maimónides Biomedical Research Institute of Córdoba: lead

Related Publications (1)

• de la Torre-Aguilar MJ, Gomez-Fernandez A, Flores-Rojas K, Martin-Borreguero P, Mesa MD, Perez-Navero JL, Olivares M, Gil A, Gil-Campos M. Docosahexaenoic and Eicosapentaenoic Intervention Modifies Plasma and Erythrocyte Omega-3 Fatty Acid Profiles But Not the Clinical Course of Children With Autism Spectrum Disorder: A Randomized Control Trial. Front Nutr. 2022 Mar 29;9:790250. doi: 10.3389/fnut.2022.790250. eCollection 2022.

  PMID: 35425788 DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder; Inflammation

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• María Mercedes Gil Campos, Doctor

  Maimónides Biomedical Research Institute of Córdoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: July 18, 2018
• First Posted: August 8, 2018
• Study Start: January 21, 2015
• Primary Completion: December 2, 2015
• Study Completion: December 2, 2015
• Last Updated: August 8, 2018

Record last verified: 2018-08