MedTrace Logo

Effect of a Wide Spectrum Nutritional Supplement on Mitochondrial Function in Children With Autism Spectrum Disorder

NCT03835117 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2025-05-09

Study results available
· View outcomes & findings →

Summary

The objective of this study is to evaluate the metabolic effects of a comprehensive wide-spectrum supplement for children with ASD to determine whether it physiologically targets mitochondrial pathways known to be abnormal in children with ASD.The intervention is a commonly used wide-spectrum nutritional supplement, which is theoretically designed to normalize mitochondrial function. The investigators aim to determine if the supplement does have the hypothesized effect on physiology in individuals with ASD. The investigator will enroll up to 50 children, aged 4 to 14 years of age with confirmed ASD and mitochondrial dysfunction, and participation will last 26 weeks.

Conditions

Interventions

DRUG

Wide-spectrum nutritional supplement

Comprehensive powder with 33 dietary supplements and 1 dietary supplement via gel capsule.

OTHER

Placebo

Inactive placebo comparator

Sponsors & Collaborators

  • Southwest Autism Research & Resource Center

    collaborator OTHER

  • Rossignol Medical Center

    lead OTHER

Principal Investigators

  • Richard E Frye, MD, PhD · Rossignol Medical Center, Phoenix AZ

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
2 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-01
Primary Completion
2022-07-31
Completion
2022-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03835117 on ClinicalTrials.gov