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

August 2, 2018 updated by: Maimónides Biomedical Research Institute of Córdoba

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 years to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental Arm
30 subjects will receive 800mg of DHA (Dietary Supplement: EuPoly-3 DHA Infant) per day.
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.
Placebo Comparator: Control Arm
30 children will take a placebo with similar lipid characteristics
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Maimónides Biomedical Research Institute of Córdoba

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: María Mercedes Gil Campos, Doctor, Maimónides Biomedical Research Institute of Córdoba

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 21, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 2, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 2, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 18, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 8, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 8, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ICI14/00355

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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