Effect of a Wide Spectrum Nutritional Supplement on Mitochondrial Function in Children With Autism Spectrum Disorder

Completed · Phase 2 · Has a placebo group

Conditions studied: Autism Spectrum Disorder

In brief

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.

Key facts

Study ID

NCT03835117

Run by

Rossignol Medical Center

People needed

16

Starts

2020-02-01

Expected to finish

2022-07-31

Last updated by the study team

2026-06-30

Who can join

Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Southwestern Research & Resource Center — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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