Omega-3 Fatty Acids + Inositol and N-acetylcysteine for Autism Spectrum Disorders
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.Treatment Details
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.
Find a clinic near you
Research locations nearbySelect from list below to view details:
Massachusetts General HospitalBoston, MA
Loading ...
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
Demarest Lloyd Jr. FoundationCollaborator