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Nutritional Supplements and Metabolite Intermediates

Mitochondrial Cocktail for Autism Spectrum Disorder (MitoASD Trial)

Phase 1
Waitlist Available
Research Sponsored by Drexel University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (0), 3 and 6 months
Awards & highlights

Summary

This trial involves giving children with autism and mitochondrial problems a special mix of vitamins and nutrients called the Mitochondrial Cocktail. The goal is to see if this treatment helps improve their condition by boosting cell energy production and protecting against damage. Researchers will check the children's progress through various tests at different stages of the treatment. The Mitochondrial Cocktail includes cofactors like L-Carnitine and the ketogenic diet, which have shown evidence for use in children with ASD.

Eligible Conditions
  • Autism Spectrum Disorder
  • Mitochondrial Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (0), 3 and 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (0), 3 and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Executive Function assessed using the Behavior Rating Inventory of Executive Function (BRIEF)
Change in features of Autistic behavior phenotype assessed using the Social Responsiveness Scale (SRS)
Secondary outcome measures
Change in buccal oxidative stress markers and mitochondrial DNA (mtDNA) damage
Changes in mitochondrial enzyme specific activities biochemically evaluated using buccal swab analysis

Side effects data

From 2016 Phase 1 & 2 trial • 54 Patients • NCT02133664
23%
Nausea
15%
Urine odor abnormal
15%
Dyspepsia
12%
Throat irritation
12%
Fatigue
8%
Incontinence
8%
Urinary tract infection
8%
Adverse drug reaction
8%
Headache
4%
Kidney Infection
4%
Deafness unilateral
100%
80%
60%
40%
20%
0%
Study treatment Arm
Lipoic Acid and Omega-3 Fatty Acids
Placebo

Trial Design

1Treatment groups
Experimental Treatment
Group I: Mitochondrial CocktailExperimental Treatment1 Intervention
The precise content of the Mitochondrial Cocktail will be: ubiquinol (liquid form, 150 mg/kg subject weight/day carnitine, 50 mg/kg subject weight/day alpha-lipoic acid, 100 mg/ day

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Who is running the clinical trial?

Drexel UniversityLead Sponsor
151 Previous Clinical Trials
48,024 Total Patients Enrolled
8 Trials studying Autism Spectrum Disorder
21,009 Patients Enrolled for Autism Spectrum Disorder
Michael J Goldenthal, PhDStudy DirectorDrexel University College of Medicine
~5 spots leftby Sep 2025
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