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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 belowSelect...
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.
Select...
My weight is between 15 and 100 kg.
Select...
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:Select...
I have serious behavioral issues that need treatment.
Select...
My child is on medication for seizures or has active epilepsy.
Select...
I have been diagnosed with a Mitochondrial Disease.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 12, week 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 12, week 24
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 moreTrial 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.
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- English is spoken at home and at least one parent can read, write, and speak English.I have serious behavioral issues that need treatment.My weight is between 15 kg and 100 kg.My educational and therapy plans have been stable for a month with no changes expected for the next 12 weeks.My current treatment and education plan has been stable for a month with no changes expected for the next 12 weeks.My medications have been the same for the last 6 weeks and won't change during the study.I do not have any health conditions that would make the treatment unsafe for me.You are currently experiencing significant symptoms or have a high level of severity in your condition.My weight is between 15 and 100 kg.I have been diagnosed with Autism Spectrum Disorder using a recognized assessment tool.My child is on medication for seizures or has active epilepsy.You are not extremely ill according to a clinical assessment.I have been diagnosed with a Mitochondrial Disease.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo control
- Group 2: Wide-spectrum nutritional supplement
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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