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Nutritional Supplement

Nutritional Supplement for Autism

Phase 2
Waitlist Available
Led By Richard E Frye, MD, PhD
Research Sponsored by Phoenix Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Weight ≥ 15 kg and ≤ 100kg;
Stable medication (no changes in past 6 weeks and no planned changes for the study duration.
Must not have
Presence of serious behavioral problems (tantrums, aggression, self-injury) for which another treatment is warranted
Children taking anticonvulsant medication for seizures or active epilepsy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 12, week 24

Summary

This trial is testing a nutritional supplement on children with ASD to see if it helps their cell power plants (mitochondria) work better. The goal is to improve their overall cell health and reduce ASD symptoms.

Who is the study for?
This trial is for children aged 4-14 with Autism Spectrum Disorder (ASD) and mitochondrial dysfunction. They must speak English at home, have a stable medication and therapy plan, weigh between 15-100 kg, and not be extremely ill or have serious behavioral issues that need other treatments.
What is being tested?
Researchers are testing if a wide-spectrum nutritional supplement can improve mitochondrial function in kids with ASD. Up to 50 participants will take either the supplement or a placebo over 26 weeks to see if there's any physiological benefit.
What are the potential side effects?
While specific side effects aren't listed, supplements could potentially cause digestive discomfort, allergic reactions, or interact with medications. Close monitoring during the trial helps identify any adverse effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My weight is between 15 kg and 100 kg.
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My medications have been the same for the last 6 weeks and won't change during the study.
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My weight is between 15 and 100 kg.
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I have been diagnosed with Autism Spectrum Disorder using a recognized assessment tool.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have serious behavioral issues that need treatment.
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My child is on medication for seizures or has active epilepsy.
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I have been diagnosed with a Mitochondrial Disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 12, week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 12, week 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in mitochondrial activity in study patients
Secondary study objectives
Change in the Aberrant Behavior Checklist (ABC) scores
Change in the Caregiver Strain Questionnaire (CGSQ) score
Change in the Childhood Autism Rating Scale (CARS) score
+8 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Wide-spectrum nutritional supplementExperimental Treatment1 Intervention
The Wide-spectrum nutritional supplement used will be a combination of NeuroNeeds: SpectrumNeeds and QNeeds. Weight based dosing will be used. The daily serving size will be divided into two oral daily doses in the form of a powder which can be mixed into liquid or food. Together, there are 34 different dietary supplements in the products. Except for ubiquinol, all of these nutrients are provided in a powder form in SpectrumNeeds. Ubiquinol is provided separately in QNeeds gel capsules. These capsules can be swallowed whole, or cut with scissors and the contents squeezed out and added to SpectrumNeeds just before ingestion.
Group II: Placebo controlPlacebo Group1 Intervention
Participants randomized to receive placebo will take placebo in an oral form divided into powder and a gel capsule in the same manner as treatment. For the second phase of the cross over, participants will be part of the opposite group they were assigned to in Phase I (Placebo or Treatment). Quantities for placebo or treatment will match across phases for each subject, utilizing the same weight based dosing.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Autism Spectrum Disorder (ASD) often target underlying physiological abnormalities, such as mitochondrial dysfunction. Nutritional supplements, like the wide-spectrum supplement studied for mitochondrial normalization, aim to improve cellular energy production and reduce oxidative stress, which may alleviate some ASD symptoms. This approach is based on the hypothesis that mitochondrial dysfunction contributes to the metabolic and neurological abnormalities seen in ASD. Other treatments, such as behavioral and educational interventions, focus on improving communication and social skills. Understanding these mechanisms is crucial as it helps tailor interventions to address specific biological and behavioral aspects of ASD, potentially leading to more effective and personalized treatment plans.
Pharmacological and dietary-supplement treatments for autism spectrum disorder: a systematic review and network meta-analysis.Dietary Supplement for Core Symptoms of Autism Spectrum Disorder: Where Are We Now and Where Should We Go?Neurologic treatment strategies in autism: an overview of medical intervention strategies.

Find a Location

Who is running the clinical trial?

Phoenix Children's HospitalLead Sponsor
74 Previous Clinical Trials
5,013,696 Total Patients Enrolled
5 Trials studying Autism Spectrum Disorder
726 Patients Enrolled for Autism Spectrum Disorder
Rossignol Medical CenterLead Sponsor
5 Previous Clinical Trials
761 Total Patients Enrolled
5 Trials studying Autism Spectrum Disorder
761 Patients Enrolled for Autism Spectrum Disorder
Southwest Autism Research & Resource CenterOTHER
8 Previous Clinical Trials
936 Total Patients Enrolled
8 Trials studying Autism Spectrum Disorder
936 Patients Enrolled for Autism Spectrum Disorder

Media Library

Wide-spectrum nutritional supplement (Nutritional Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT03835117 — Phase 2
Autism Spectrum Disorder Research Study Groups: Placebo control, Wide-spectrum nutritional supplement
Autism Spectrum Disorder Clinical Trial 2023: Wide-spectrum nutritional supplement Highlights & Side Effects. Trial Name: NCT03835117 — Phase 2
Wide-spectrum nutritional supplement (Nutritional Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03835117 — Phase 2
~1 spots leftby Jan 2025