Effect of a Wide Spectrum Nutritional Supplement on Mitochondrial Function in Children With Autis… (NCT03835117) | Clinical Trial Compass
CompletedPhase 2
Effect of a Wide Spectrum Nutritional Supplement on Mitochondrial Function in Children With Autism Spectrum Disorder
United States16 participantsStarted 2020-02-01
Plain-language summary
The objective of this study is to evaluate the metabolic effects of a comprehensive wide-spectrum supplement for children with ASD to determine whether it physiologically targets mitochondrial pathways known to be abnormal in children with ASD.The intervention is a commonly used wide-spectrum nutritional supplement, which is theoretically designed to normalize mitochondrial function. The investigators aim to determine if the supplement does have the hypothesized effect on physiology in individuals with ASD. The investigator will enroll up to 50 children, aged 4 to 14 years of age with confirmed ASD and mitochondrial dysfunction, and participation will last 26 weeks.
Who can participate
Age range
2 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Weight ≥ 15 kg and ≤ 100kg;
* DSM-5 diagnosis of Autism Spectrum Disorder as established by formal clinical assessment which includes a gold-standard tool such as the Autism Diagnostic Observational Schedule.
* Current Clinical Global Impression Severity score ≥ 4
* Stable educational and therapy plan (one month) with no planned changes in the intensity of treatment for 12 weeks.
* English is spoken in the home and at least one parent is able to read, write and speak English.
* Stable medication (no changes in past 6 weeks and no planned changes for the study duration.
* Electron Transport Chain Complex (I, II, III, IV) or Citrate Synthase Activity which is \>= 2.0 Standard Deviation Above or Below Average (outside the normal range)
Exclusion Criteria:
* Presence of serious behavioral problems (tantrums, aggression, self-injury) for which another treatment is warranted.
* Current Clinical Global Impression Severity score \< 7 (Extremely Ill)
* Significant medical condition by history or by physical examination or lab tests that would be incompatible with the treatment.
* Children taking anticonvulsant medication for seizures or active epilepsy.
* Diagnosis of Mitochondrial Disease
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Mitochondrial Activity in Study Patients: Citrate Synthase
Timeframe: Before (Baseline), After Part I (Week 12), After Part 2 (Week 24)
2
Change in Mitochondrial Activity in Study Patients: Complex I
Timeframe: Before (Baseline), After Part I (Week 12), After Part 2 (Week 24)
3
Change in Mitochondrial Activity in Study Patients: Complex II
Timeframe: Before (Baseline), After Part I (Week 12), After Part 2 (Week 24)
4
Change in Mitochondrial Activity in Study Patients: Complex IV
Timeframe: Before (Baseline), After Part I (Week 12), After Part 2 (Week 24)