Wide-spectrum nutritional supplement for Autism Spectrum Disorder

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Autism Spectrum Disorder+3 More
Wide-spectrum nutritional supplement - Drug
Eligibility
< 18
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Autism Spectrum Disorder
  • Autism Spectrum Disorders

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 11 Secondary · Reporting Duration: Baseline, Week 12, Week 24

Week 24
Change in mitochondrial activity in study patients
Change in the Caregiver Strain Questionnaire (CGSQ) score
Change in the Childhood Autism Rating Scale (CARS) score
Change in the Children's Yale-Brown Obsessive Compulsive Scale modified for Autism Spectrum Disorder (CYBOCS-ASD) score
Change in the Clinical Global Impression scale (CGI) score
Change in the Parent-rated Anxiety Scale for ASD (PRAS-ASD) score
Change in the Vineland III Caregiver score
Examine the change in attention to social stimuli
Week 24
Change in the Aberrant Behavior Checklist (ABC) scores
Evaluate intervention effect on cellular regulatory pathways known to be implicated in ASD
Evaluate intervention safety
Examine the change in cognitive ability

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

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

Wide-spectrum nutritional supplement
Drug
Experimental Group · 1 Intervention: Wide-spectrum nutritional supplement · Intervention Types: Drug
Placebo control
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, week 12, week 24

Who is running the clinical trial?

Rossignol Medical CenterLead Sponsor
4 Previous Clinical Trials
794 Total Patients Enrolled
4 Trials studying Autism Spectrum Disorder
794 Patients Enrolled for Autism Spectrum Disorder
Southwest Autism Research & Resource CenterOTHER
4 Previous Clinical Trials
336 Total Patients Enrolled
4 Trials studying Autism Spectrum Disorder
336 Patients Enrolled for Autism Spectrum Disorder
Phoenix Children's HospitalLead Sponsor
68 Previous Clinical Trials
5,011,583 Total Patients Enrolled
5 Trials studying Autism Spectrum Disorder
804 Patients Enrolled for Autism Spectrum Disorder
Richard E Frye, MD, PhDPrincipal InvestigatorRossignol Medical Center, Phoenix AZ
5 Previous Clinical Trials
804 Total Patients Enrolled
5 Trials studying Autism Spectrum Disorder
804 Patients Enrolled for Autism Spectrum Disorder

Eligibility Criteria

Age < 18 · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are taking the same medication for at least 6 weeks.
You have at least 2 of the following: you have an electron transport chain complex (I, II, III, IV) or citrate synthase activity which is ≥ 2.0 standard deviation above or below average.
You have a diagnosis of autism spectrum disorder.

About The Reviewer

Michael Gill preview

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?
Pennsylvania66.7%
New York33.3%
How old are they?
18 - 65100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%