ASDNCT03620097
Evaluate the Efficacy and Safety of DHA in the Adjuvant Treatment of Children With ASD.
A study testing EuPoly-3 DHA Infant in people with ASD, run by Maimónides Biomedical Research Institute of Córdoba.
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. Read more about this study
- Who is it for?
- Ages 2 to 5 years
- Conditions the study is for
- ASD
- What is being tested?
- EuPoly-3 DHA Infant
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 21 Jan 2015to 2 Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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).
About this study
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.
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.
Read the 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.
- Conditions
- ASD
- Being tested
- EuPoly-3 DHA Infant, Placebo
- Keywords
- Autism Spectrum Disorders, ASD, Children, Autism, Docosahexaenoic acid, Inflammation, Oxidative stress, Intestinal microbiota, heavy metals
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EuPoly-3 DHA InfantDietary 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.
PlaceboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | 30 subjects will receive 800mg of DHA (Dietary Supplement: EuPoly-3 DHA Infant) per day. Receives: Dietary Supplement: EuPoly-3 DHA Infant |
| Control Arm | Placebo comparator | 30 children will take a placebo with similar lipid characteristics Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start21 Jan 2015
- Primary completion2 Dec 2015
- Study completion2 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ASDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maimónides Biomedical Research Institute of Córdoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- María Mercedes Gil Campos, Doctor, Principal investigator, Maimónides Biomedical Research Institute of Córdoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03620097
- Sponsor's protocol ID
- ICI14/00355
- Status last verified
- Aug 2018
- First submitted
- 18 Jul 2018
- Last updated
- 8 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35425788
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03620097
- Acronym / sponsor ID
- ICI14/00355
- Conditions
- ASD
- Keywords
- Autism Spectrum Disorders, ASD, Children, Autism, Docosahexaenoic acid, Inflammation, Oxidative stress, Intestinal microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Maimónides Biomedical Research Institute of CórdobaUniversity, hospital or other
- Study start
- 21 Jan 2015 (actual)
- Primary completion
- 2 Dec 2015 (actual)
- Study completion
- 2 Dec 2015 (actual)
- First posted
- 8 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Dietary Supplement: EuPoly-3 DHA Infant30 subjects will receive 800mg of DHA (Dietary Supplement: EuPoly-3 DHA Infant) per day. |
| Control Arm | Placebo comparator | Other: Placebo30 children will take a placebo with similar lipid characteristics |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EuPoly-3 DHA InfantChildren 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. | Dietary supplement | Experimental Arm |
| PlaceboChildren 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 | Control Arm |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2018.
- Derived from this study: PubMed 35425788de 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
María Mercedes Gil Campos, Doctor principal investigator
Maimónides Biomedical Research Institute of Córdoba
Questions about this trial
What is this clinical trial studying?
A study testing EuPoly-3 DHA Infant in people with ASD, run by Maimónides Biomedical Research Institute of Córdoba.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma and erythrocytic level of DHA (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03620097, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2018.