Omega-3 Fatty Acids + Inositol and N-acetylcysteine for Autism Spectrum Disorders

Recruiting in Palo Alto (17 mi)

Overseen ByJanet Wozniak, MD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: Massachusetts General Hospital

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial tests natural supplements like omega-3 fatty acids, inositol, and NAC to help children and teens with NVLD or ASD who have mood issues. These supplements aim to improve brain health and reduce inflammation to stabilize their mood. Omega-3 fatty acids have been studied for their potential benefits in children with ASD, but results have been inconsistent.

Eligibility Criteria

This trial is for children and adolescents aged 5-17 with non-verbal learning disability (NVLD) or Autism Spectrum Disorder (ASD), who have trouble managing their emotions. They must be able to swallow pills, understand English well enough for study requirements, and use a computer with internet for remote assessments. Exclusions include an IQ below 70, certain medical conditions, risk of suicide, pregnancy, nursing mothers, or known sensitivity to the trial supplements.

Inclusion Criteria

You have been diagnosed with non-verbal learning disability or Autism Spectrum Disorder, or have specific scores on a behavior checklist.

Subjects and their caregivers must be English-speaking and have a level of understanding sufficient to communicate intelligently with the investigator and study coordinator, and to cooperate with all tests and examinations required by the protocol.

You have severe symptoms of anxiety, depression, aggression, and attention issues.

+4 more

Exclusion Criteria

Your IQ is less than 70.

You weigh less than 12.5 kilograms.

You have a seizure disorder that is not under control or not being treated.

+11 more

Participant Groups

The study tests natural treatments: Omega-3 fatty acids plus Inositol versus N-acetylcysteine (NAC) over six weeks to see which is better at helping kids with NVLD/ASD manage mood swings. It's an open-label trial where both researchers and participants know what treatment is being given.

2Treatment groups

Experimental Treatment

Group I: Omega-3 Fatty Acids + InositolExperimental Treatment1 Intervention

Subjects will be treated with 1020mg QAM + 1020mg QPM of omega-3 fatty acids and inositol based on weight (subjects under 25kg: 1000mg QD; Subjects weighing 25kg or more: 2000mg QD).

Group II: N-acetylcysteineExperimental Treatment1 Intervention

Subjects will be treated with N-acetylcysteine capsules (subjects ages 5-12: 1800mg QD; subjects ages 13-17: 2400 mg QD) or effervescent tablets (subjects ages 5-12: 1800mg QD; subjects ages 13-17: 2700 mg QD) based on age.