Fish oil compound tested as autism symptom treatment
NCT ID NCT01260961
First seen Jun 30, 2026 · Last updated Jul 01, 2026 · Updated 1 time
Summary
This study tests whether DHA, a key omega-3 fatty acid found in fish oil, can improve symptoms of autism in children and adolescents aged 5 to 17. Participants receive either DHA or a placebo daily for 12 weeks. Researchers also look at genes and urine markers related to DHA to understand how it might work.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Docosahexaenoic acid (DHA), an omega-3 fatty acid found in fish oil
- What this could lead to
- If DHA is effective, it could offer a simple dietary supplement to help reduce autism symptoms in some children.
- What could go wrong
- This is an early-stage trial with a small number of participants, so results may not apply broadly. DHA may show no benefit over placebo.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 132 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2010
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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5 to 17 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Meets DSM-IV, ADI, and ADOS criteria for autistic disorder * Age 5-17. * Outpatients * Parent or legal guardian signing informed consent, and assent documented for patient with demonstrated capacity to provide it. * Sexually active females of childbearing potential must use an acceptable method of birth control (oral contraceptive medications \[the administration of which must be supervised by a parent or guardian\], IUD, depot medication, double barrier or tubal ligation) and have a negative serum pregnancy test prior to entry into the study. * Subjects with history of seizures, who have been seizure-free for more than or equal to 6 months on a stable dose of anticonvulsant medication.Non-medicated subjects with a history of seizures who have been seizure-free for more than or equal to 6 months.Subjects with abnormal EEG but no clinical seizures. Exclusion Criteria: * Subjects who are pregnant or nursing mothers. * Sexually active females of childbearing potential who are not using adequate birth control measures (detailed above in inclusion criteria). * Subjects with overall adaptive behavior scores below the age of two years on the Vineland Adaptive Behavior Rating Scale. * Subjects with active or unstable epilepsy. * 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. * Subjects who are a serious suicidal risk. * Subjects with clinically significant or unstable medical illness that would contraindicate participation in the study, including hematopoietic or cardiovascular disease, pancreatitis, liver toxicity, and polycystic ovary syndrome * Subjects reporting history of encephalitis, phenylketonuria, tuberous sclerosis, fragile X syndrome, anoxia during birth, pica, neurofibromatosis, hypomelanosis of Ito, hypothyroidism, Duchenne muscular dystrophy, and maternal rubella. * Patients with history of the following:gastrointestinal, liver, or kidney, or other known conditions which will presently interfere presently with the absorption, distribution, metabolism, or excretion of drugs, cerebrovascular disease or brain trauma, clinically significant unstable endocrine disorder, such as hypo- or hyperthyroidism, recent history or presence of any form of malignancy * Treatment within the previous 30 days with any drug known to a well-defined potential for toxicity to a major organ * Subjects with clinically significant abnormalities in laboratory tests or physical exam * Subjects likely to require ECT. * Subjects unable to tolerate taper from psychoactive medication if necessary. * Subjects with a history of hypersensitivity or severe side effects associated with the use of divalproex sodium, or other an ineffective prior therapeutic trial of omega three fatty acids. * Subjects who have received any of the following interventions within the prescribed period before starting treatment-investigational drugs within the previous 30 days. * Subjects who have begun any new alternative non-medication treatments, such as diet, vitamins, and psychosocial therapy, within the previous three months. * Subjects with any organic or systemic disease or patients who require a therapeutic intervention, not otherwise specified, which would confound the evaluation of the safety of the study medication. * Subjects who reside in a remote geographical area who do not have regular access to transportation to the clinical facility. * If a patient is not doing well enough (defined by CGI-AD Severity score of 3-"mildly ill" or better)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Rutgers
Piscataway, New Jersey, 08854, United States
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Other studies related to the condition(s) this trial covers.
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