Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03835117 · ClinicalTrials.gov registry record · Phase 2
Effect of a Wide Spectrum Nutritional Supplement on Mitochondrial Function in Children With Autism Spectrum Disorder
A Phase 2 study of Autism Spectrum Disorder, sponsored by Rossignol Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT03835117: Completed Phase 2 study of Autism Spectrum Disorder, sponsored by Rossignol Medical Center.
NCT03835117 is a Phase 2 study of Autism Spectrum Disorder that has completed, run by Rossignol Medical Center. The registered enrollment target is 16 participants, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03835117, a Phase 2 study of Autism Spectrum Disorder, has completed, sponsored by Rossignol Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Mitochondrial activity and redox metabolism at baseline and after the placebo and supplement arms of the study, as determined through laboratory assessment. Normal Range 4.4 to 22 with Mean and SD of 12.1 and 5.1. It is better to be within the normal range than outside of the normal range regardless of whether the value is higher or lower.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Wide-spectrum nutritional supplement
Study Locations (1)
Arizona
- Southwestern Research & Resource Center - Phoenix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2020-02-01 |
| Est. Completion | 2022-07-31 |
| Phase | Phase 2 |
What the finished NCT03835117 record still lists
NCT03835117 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (88% lower).
The record links to 1 condition, with Autism Spectrum Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03835117 reports a single indexed study location in Arizona.
Frequently Asked Questions
What is clinical trial NCT03835117 about?
NCT03835117 is a clinical study titled "Effect of a Wide Spectrum Nutritional Supplement on Mitochondrial Function in Children With Autism Spectrum Disorder". 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 nutrit...
What is the current status of trial NCT03835117?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 16 participants. The study started on 2020-02-01. Estimated completion is 2022-07-31.
What conditions does trial NCT03835117 study?
This clinical trial studies the following conditions: Autism Spectrum Disorder.
What interventions are being tested in trial NCT03835117?
The interventions under investigation include: Placebo (OTHER), Wide-spectrum nutritional supplement (DRUG).
Who is sponsoring clinical trial NCT03835117?
This trial is sponsored by Rossignol Medical Center, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03835117 being conducted?
This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Autism Spectrum Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03835117's enrollment target sits among peer trials
16 208th of 224 higher than 17 of 224 other Autism Spectrum Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Autism Spectrum Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Pimavanserin for Rigid-compulsive Symptoms in Autism Spectrum Disorder
RECRUITING · Phase 2
-
Targeting the Neurobiology of RRB in Autism Using N-acetylcysteine: Trial
RECRUITING · Phase 2
-
Early Treatment of Language Impairment in Young Children With Autism Spectrum Disorder With Leucovorin Calcium
RECRUITING · Phase 2
-
Optimizing Outcomes for Young Autistic Children
RECRUITING · Phase 2
-
Trial of Zolpidem for Sleep in Children With Autism
RECRUITING · Phase 2
-
Telehealth-Enabled Versus In-Person Parent-Mediated Behavioral Treatment for Challenging Behaviors in Children With ASD
RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02422641 · 16 participants · Phase 2
Prospective Evaluation Of High-Dose Systemic Methotrexate In Patients With Breast Cancer And Leptomeningeal Metastasis
- NCT02851758 · 16 participants · NA
Transplantation of Autologously Derived Mitochondria Following Ischemia
- NCT03291028 · 16 participants
Analysis of Primary and Metastatic Tumors in Patients With Renal Cell Carcinoma and Urothelial Carcinoma
- NCT03425526 · 16 participants · Phase 1
Donor T Cell Therapy in Treating Immunocompromised Patients With Adenovirus-Related Disease
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI