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 range2 Years – 17 Years

SexALL

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

What they're measuring

Change in Mitochondrial Activity in Study Patients: Citrate Synthase

Timeframe: Before (Baseline), After Part I (Week 12), After Part 2 (Week 24)

Change in Mitochondrial Activity in Study Patients: Complex I

Timeframe: Before (Baseline), After Part I (Week 12), After Part 2 (Week 24)

Change in Mitochondrial Activity in Study Patients: Complex II

Timeframe: Before (Baseline), After Part I (Week 12), After Part 2 (Week 24)

Change in Mitochondrial Activity in Study Patients: Complex IV

Timeframe: Before (Baseline), After Part I (Week 12), After Part 2 (Week 24)

Trial details

NCT IDNCT03835117

SponsorRossignol Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-07-31

Results submitted2024-12-23

View on ClinicalTrials.gov More Autism Spectrum Disorder trials