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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether Docosa Hexanoic Acid (DHA), a key omega-3 fatty acid in fish oil, can reduce symptoms of autism in children and adolescents. Participants will receive either DHA or a placebo (a pill with no active ingredient) over 12 weeks to assess any improvements. The study will also examine genes and urine markers related to DHA. Children and teens aged 5-17 with an autism diagnosis, who have been stable for at least six months without seizures, might be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance autism treatment options.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Docosa Hexanoic Acid (DHA), a key omega-3 fatty acid in the brain, is generally safe for people. Studies have used DHA in children with autism without causing serious side effects. One study found that giving DHA to children aged 2 to 6 years with autism did not cause major health issues over six months. Another review noted that omega-3 fatty acids, like DHA, are well-tolerated by people with Autism Spectrum Disorder (ASD).

Mild side effects, such as an upset stomach or a fishy aftertaste, might occur but are not serious. DHA is also found in common foods like fish oil, which many people consume regularly without problems. The evidence so far suggests that children and teenagers can safely take DHA, making it a promising option to explore for autism treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Docosahexaenoic Acid (DHA) is unique because it offers a potential new approach for autism treatment by leveraging its role as an omega-3 fatty acid, which is essential for brain health. Unlike current treatments that primarily focus on behavioral therapy or medications to manage symptoms, DHA aims to improve neurological function by enhancing brain cell communication and reducing inflammation. Researchers are excited about DHA because it taps into a nutritional angle, offering a more natural and possibly safer alternative with fewer side effects than traditional medications.

What evidence suggests that DHA might be an effective treatment for autism?

This trial will compare Docosahexaenoic Acid (DHA) with a placebo to evaluate its effects on children with Autism Spectrum Disorder (ASD). Research has shown that DHA, a key omega-3 fatty acid, might benefit children with ASD. One study found that DHA, when combined with another omega-3 called EPA, improved thinking skills like memory and attention in children with ASD. However, other research found that omega-3s, including DHA, had only a small and not significant effect on autism-related behaviors. Overall, the evidence remains mixed, and more studies are needed to understand how DHA might affect autism symptoms. ^{4 5 6 7 8}

Who Is on the Research Team?

Sherie Novotny, MD

Principal Investigator

Rutgers-RWJMS

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11892077/

Impact of Omega-3 Fatty Acids on Cognitive Outcomes in ... Results suggested that DHA and EPA supplementation may improve cognitive functions such as memory, attention, and executive functioning in children with ASD.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S3050656525001142

The effect of omega-3 fatty acid supplementation on autism ... Overall, Omega-3 fatty acids have a minor and insignificant effect on ASD behaviors, which may be related to treatment protocol and appropriateness of ...

3. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2023.1238973/full

Omega-3 polyunsaturated fatty acids and/or vitamin D in ... The review found that the effects of omega-3 supplementation on ASD were too weak to conclude that core symptoms were alleviated. Vitamin D supplementation ...

4. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-016-1428-8

Vitamin D and omega-3 fatty acid supplements in children with ... Evidence shows that children with ASD have an increased omega-6 to omega-3 ratio in blood and low blood concentrations of n-3 LCPUFAs, which ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03620097?cond=ASD&viewType=Table&rank=7

Evaluate the Efficacy and Safety of DHA in the Adjuvant ... Randomized Double-blind, Parallel-group Clinical Trial, Placebo Control, to Evaluate the Efficacy and Safety of Docoxahenoic Acid in the Adjuvant Treatment of ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2710498/

Omega-3 Fatty Acids for Autistic Spectrum Disorder We conducted a systematic review to determine the safety and efficacy of omega-3 fatty acids for autistic spectrum disorder (ASD).

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0899900713001962

Impact of nutrition on serum levels of docosahexaenoic ... Our results showed that children with ASD had lower dietary consumption of foodstuff containing DHA, as well as lower serum levels of DHA than controls.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9002234/

A Randomized Control Trial - PMC - PubMed Central A double-blind, randomized placebo-controlled intervention with DHA/EPA for 6 months was carried out in 54 children between 2 and 6 years diagnosed with ASD.