Study Summary
This trial is testing whether a nutritional supplement can help normalize mitochondrial function in children with ASD and mitochondrial dysfunction. Up to 50 children aged 4-14 will be enrolled and participate for 26 weeks.
- Autism Spectrum Disorder
- Autism Spectrum Disorders
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 11 Secondary · Reporting Duration: Baseline, Week 12, Week 24
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Wide-spectrum nutritional supplement
1 of 2
Placebo control
1 of 2
Experimental Treatment
Non-Treatment Group
50 Total Participants · 2 Treatment Groups
Primary Treatment: Wide-spectrum nutritional supplement · Has Placebo Group · Phase 2
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age < 18 · All Participants · 7 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:About The Reviewer
Michael Gill - B. Sc.
First Published: October 4th, 2021
Last Reviewed: November 6th, 2022
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
Who else is applying?
What state do they live in?
| Pennsylvania | 66.7% |
| New York | 33.3% |
How old are they?
| 18 - 65 | 100.0% |
What portion of applicants met pre-screening criteria?
| Did not meet criteria | 100.0% |
- Delhey, Leanna, Ekim Nur Kilinc, Li Yin, John Slattery, Marie Tippett, Shannon Rose, Sirish Bennuri, et al.. 2017. “The Effect of Mitochondrial Supplements on Mitochondrial Activity in Children with Autism Spectrum Disorder”. Journal of Clinical Medicine. MDPI AG. doi:10.3390/jcm6020018.
- Frye, Richard Eugene, and Daniel A. Rossignol. 2014. “Treatments for Biomedical Abnormalities Associated with Autism Spectrum Disorder”. Frontiers in Pediatrics. Frontiers Media SA. doi:10.3389/fped.2014.00066.
- Rose, Shannon, Dmitriy M. Niyazov, Daniel A. Rossignol, Michael Goldenthal, Stephen G. Kahler, and Richard E. Frye. 2018. “Clinical and Molecular Characteristics of Mitochondrial Dysfunction in Autism Spectrum Disorder”. Molecular Diagnosis & Therapy. Springer Science and Business Media LLC. doi:10.1007/s40291-018-0352-x.
- Richard Eugene Frye 2020. "Effect of a Wide Spectrum Nutritional Supplement on Mitochondrial Function in Children With Autism Spectrum Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03835117.