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Nutritional Supplement for Autism
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- 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.
- Group 1: Placebo control
- Group 2: Wide-spectrum nutritional supplement
- 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.
Frequently Asked Questions
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."
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."
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."
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."
Who else is applying?
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What portion of applicants met pre-screening criteria?
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