What side effects are associated with this type of intervention?

Common treatments for Autism Spectrum Disorder (ASD) that are similar to wide-spectrum nutritional supplements include various vitamins and minerals such as vitamin B6, magnesium, and antioxidants like Coenzyme Q10. Known side effects of these treatments can include gastrointestinal issues, such as nausea and diarrhea, and potential interactions with other medications. High doses of vitamins and minerals may also lead to toxicity and other adverse effects. It is important to monitor for side effects and consult with a healthcare provider when using these supplements.

What prior FDA approvals exist?

The FDA has approved two medications for the treatment of irritability associated with Autism Spectrum Disorder: risperidone and aripiprazole. These antipsychotic drugs help manage symptoms such as aggression, self-injury, and severe tantrums. There are no FDA-approved treatments specifically targeting mitochondrial function in ASD. The wide-spectrum nutritional supplement being studied aims to normalize mitochondrial function, but this approach is still under investigation and not yet approved by the FDA.

What other types of research exist?

Promising alternatives to wide-spectrum nutritional supplements for ASD patients include: 1) Omega-3 fatty acids, which have shown small beneficial effects on language, social deficits, and associated symptoms despite inconsistent findings. 2) Methylcobalamin and folinic acid, which have been linked to improvements in adaptive behavior related to glutathione metabolism. 3) N,N-dimethylglycine, which has been reported to be beneficial in some studies. These alternatives should be discussed with a healthcare provider to determine their suitability and potential benefits for individual patients.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 12, week 24

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Wide-spectrum nutritional supplement

2020

Completed Phase 2

~20

0 / 7Eligibility criteria met

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.