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Nutritional Supplements and Metabolite Intermediates
Does Clinical Treatment of Mitochondrial Dysfunction Impact Autism Spectrum Disorder (ASD)? (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
All Individual Drugs Already Approved
Approved for 10 Other Conditions
No Placebo-Only Group
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
- Mitochondrial Disorder
- Autism Spectrum Disorder
- Mitochondrial Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (0), 3 and 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (0), 3 and 6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Change in buccal oxidative stress markers and mitochondrial DNA (mtDNA) damage
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
Find a Location
Who is running the clinical trial?
Drexel UniversityLead Sponsor
155 Previous Clinical Trials
48,172 Total Patients Enrolled
Michael J Goldenthal, PhDStudy DirectorDrexel University College of Medicine