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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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 12, week 24

Awards & highlights

Study Summary

This trial is testing whether a nutritional supplement can help normalize mitochondrial function in children with ASD and mitochondrial dysfunction. Up to 50 children aged 4-14 will be enrolled and participate for 26 weeks.

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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in mitochondrial activity in study patients

Secondary outcome measures

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.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Phoenix Children's HospitalLead Sponsor

73 Previous Clinical Trials

5,013,938 Total Patients Enrolled

5 Trials studying Autism Spectrum Disorder

804 Patients Enrolled for Autism Spectrum Disorder

Rossignol Medical CenterLead Sponsor

4 Previous Clinical Trials

794 Total Patients Enrolled

4 Trials studying Autism Spectrum Disorder

794 Patients Enrolled for Autism Spectrum Disorder

Southwest Autism Research & Resource CenterOTHER

6 Previous Clinical Trials

876 Total Patients Enrolled

6 Trials studying Autism Spectrum Disorder

876 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research initiative currently recruiting participants?

"As per the information on clinicaltrials.gov, this study is not actively recruiting at present; it was initially posted on February 1st 2020 and last edited September 26th 2022. Nevertheless, there are presently 269 other studies that require participants to join them."

Answered by AI

Has the FDA certified Wide-spectrum nutritional supplement?

"Our team at Power assessed the safety of this Wide-spectrum nutritional supplement and gave it a rating of 2 on account of its Phase 2 status, evidencing some safety data but no efficacy."

Answered by AI

Do participants of this experiment need to be younger than 80 years old?

"This clinical study is only open to minors, with the age limit of participants being between 2 and 17 years old. According to government data, 227 medical trials are available for children under 18 while 42 studies are designed for seniors over 65."

Answered by AI

Is my eligibility sufficient to partake in this clinical trial?

"The requirements for enrolment in this trial include a diagnosis of autism spectrum disorder and an age between 2-17 years old. At present, there are roughly 50 spots open to qualified applicants."

Answered by AI