DHA for Autism

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Rutgers, The State University of New Jersey

Must be taking: Anticonvulsants

Must not be taking: Psychoactive medications

Disqualifiers: Pregnancy, Schizophrenia, Epilepsy, others

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

132 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that subjects unable to tolerate tapering from psychoactive medication may be excluded, suggesting that some medication adjustments might be necessary.

What data supports the effectiveness of the treatment Docosahexanoic Acid for autism?

Some studies suggest that omega-3 fatty acids, which include docosahexaenoic acid (DHA), may help improve certain symptoms of autism, such as social interaction and repetitive behaviors. However, the evidence is not strong enough to confirm their effectiveness, and more research is needed. ^{1 2 3 4 5}

Is DHA (Docosahexanoic Acid) safe for humans?

Some studies suggest that omega-3 fatty acids, which include DHA, are generally well tolerated in children with autism, but there is not enough scientific evidence to confirm their safety conclusively. ^{1 3 5 6 7}

How does the treatment DHA differ from other treatments for autism?

DHA (docosahexaenoic acid) is unique because it is a type of omega-3 fatty acid that may help improve symptoms of autism by supporting brain health and development. Unlike other treatments, DHA is a dietary supplement that can be taken to potentially improve social interaction and reduce repetitive behaviors in children with autism. ^{2 8 9 10 11}

What is the purpose of this trial?

Dr. Sherie Novotny of the Department of Psychiatry at UMDNJ-RWJMS and collaborators are starting a treatment trial to determine whether Docosa Hexanoic Acid(DHA), the major omega-3 fatty acid found in the brain and a component of fish oil, has any effects on the symptoms of autism. We propose to carry out a trial to test the effect of DHA compared to a placebo (a pill with no drug in it) on several aspects of autism in children and adolescents, in a 12-week clinical study with children or adolescents in the age group of 5-17 with a diagnosis of Autism Spectrum Disorder. Additionally this trial will study genes related to the therapeutic agent, DHA, and biomarkers related to DHA in the urine.

Research Team

Sherie Novotny, MD

Principal Investigator

Rutgers-RWJMS

Eligibility Criteria

This trial is for children and adolescents aged 5-17 with Autism Spectrum Disorder. Participants must meet specific autism diagnostic criteria, be seizure-free for at least 6 months if applicable, and capable of giving consent through a guardian. Sexually active females must use birth control. Those with certain medical conditions or on recent psychoactive medications are excluded.

Inclusion Criteria

I am between 5 and 17 years old.

My EEG results were abnormal, but I haven't had any seizures.

Meets DSM-IV, ADI, and ADOS criteria for autistic disorder

Exclusion Criteria

I am not pregnant or nursing.

I am a woman who can have children and am not using effective birth control.

Subjects with any of the following past or present mental disorders: schizophrenia, schizoaffective disorder, major depressive disorder, bipolar I or II disorders or substance abuse disorders

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive DHA or placebo for 12 weeks to assess effects on autism symptoms

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Long-term monitoring

Monitoring of oxidative stress biomarkers and phenotypic features of autism over three years

Three years

Treatment Details

Interventions

• Docosahexanoic Acid
• Placebo

Trial Overview The study tests the effects of Docosahexanoic Acid (DHA), an omega-3 fatty acid found in fish oil, against a placebo over 12 weeks to see if it improves symptoms of autism. It also examines genetic factors related to DHA and its biomarkers in urine.

Participant Groups

Group I: Docosa Hexanoic Acid Active Control 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

Findings from Research

In a pilot study involving 10 children aged 4-7 with autism spectrum disorder (ASD), 8 out of 9 participants who completed the study showed about a 33% improvement in autism symptoms after taking 1 gram of omega-3 fatty acids daily for 12 weeks.

The study found omega-3 fatty acids to be safe, with no reported side effects, suggesting they may be a beneficial intervention for children with ASD, although further research with larger groups is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Omega 3 fatty acid treatment in autism. Meiri, G., Bichovsky, Y., Belmaker, RH.[2009]

References

1. United States pubmed.ncbi.nlm.nih.gov

Role of polyunsaturated fatty acids in the management of Egyptian children with autism. [2013]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Relationship between Long Chain n-3 Polyunsaturated Fatty Acids and Autism Spectrum Disorder: Systematic Review and Meta-Analysis of Case-Control and Randomised Controlled Trials. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Omega 3 fatty acid treatment in autism. [2009]

4. United States pubmed.ncbi.nlm.nih.gov

Dietary docosahexaenoic acid supplementation in children with autism. [2014]

5. United States pubmed.ncbi.nlm.nih.gov

Omega-3 fatty acids for autistic spectrum disorder: a systematic review. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Equity, acceptability and feasibility of using polyunsaturated fatty acids in children and adolescents with autism spectrum disorder: a rapid systematic review. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

A pilot randomized controlled trial of omega-3 fatty acids for autism spectrum disorder. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Impact of nutrition on serum levels of docosahexaenoic acid among Omani children with autism. [2016]

9. England pubmed.ncbi.nlm.nih.gov

Vitamin D and omega-3 fatty acid supplements in children with autism spectrum disorder: a study protocol for a factorial randomised, double-blind, placebo-controlled trial. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Dietary DHA, bioaccessibility, and neurobehavioral development in children. [2019]

11. England pubmed.ncbi.nlm.nih.gov

The fatty acid compositions of erythrocyte and plasma polar lipids in children with autism, developmental delay or typically developing controls and the effect of fish oil intake. [2021]