Status:
COMPLETED
Effect of a Wide Spectrum Nutritional Supplement on Mitochondrial Function in Children With Autism Spectrum Disorder
Lead Sponsor:
Rossignol Medical Center
Collaborating Sponsors:
Southwest Autism Research & Resource Center
Conditions:
Autism Spectrum Disorder
Eligibility:
All Genders
2-17 years
Phase:
PHASE2
Brief 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 pathway...
Detailed Description
Autism spectrum disorder (ASD) is a heterogeneous neurodevelopmental disorder often with life-long consequences that affects young children during critical developmental periods. The Centers for Disea...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2022
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT03835117
Start Date
February 1 2020
End Date
July 31 2022
Last Update
May 9 2025
Active Locations (1)
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1
Southwestern Research & Resource Center
Phoenix, Arizona, United States, 85016