Trial Outcomes & Findings for Effect of a Wide Spectrum Nutritional Supplement on Mitochondrial Function in Children With Autism Spectrum Disorder (NCT NCT03835117)

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

Mitochondrial activity and redox metabolism at baseline and after the placebo and supplement arms of the study, as determined through laboratory assessment. Normal Range 4.4 to 22 with Mean and SD of 12.1 and 5.1. It is better to be within the normal range than outside of the normal range regardless of whether the value is higher or lower.

Mitochondrial activity and redox metabolism at baseline and after the placebo and supplement arms of the study, as determined through laboratory assessment. Normal range is 3.4 to 11.9 with a mean of 7.65. Outside of the normal range is worse regardless of whether it is above or below the normal range.

Mitochondrial activity and redox metabolism at baseline and after the placebo and supplement arms of the study, as determined through laboratory assessment. Normal Range (mean ±SD) 0.03 -- 0.35 (0.194 ±0.08). It is better to be within the normal range regardless of whether the value is above or below the normal range

Mitochondrial activity and redox metabolism at baseline and after the placebo and supplement arms of the study, as determined through laboratory assessment. Normal Range (mean ±SD) 0.15 -- 0.6 (0.31 ±0.1). Better scores are inside the normal range regardless of if they are higher or lower.

The Childhood Autism Rating Scale is a 15-item clinician-rated scale that measures the severity of core ASD symptoms of social communication and restricted and repetitive patterns of behavior, interests, or activities. Each item is scored on a 4 point scale of severity from 1 (None/Minimal) to 4 (Severe). Minimal score is 15 and maximal score is 60. The measure is the total score of the 15 items in which a score of 15-27.5 reflects minimal to no severity of symptoms, 28-33.5 reflects mild to moderate severity of symptoms, and a score of 34 or higher reflects severe symptoms. Lower scores are better.

The Clinical Global Impression - Severity scale (CGI-S) is a clinician rated 7-point measure of overall symptomatic severity of psychopathology. Scores range from 1 (Normal, not at all ill) through 4 (Moderately ill) to 7 (Among the most extremely ill patients). Lower scores are better.

The Children's Yale-Brown Obsessive Compulsive Scale modified for Autism Spectrum Disorder is a 5-item clinician-rated measure to evaluate severity of repetitive behavior in children with ASD. Each item is scored on a 5 point scale from 0 (None) to 4 (Extreme) for the severity of: Time Spent, Interference in everyday life, Distress, Resistance, and Degree of Control over the behavior. A total score ranges from 0 to 20. Lower scores are better.

The Aberrant Behavior Checklist is a 58-item caregiver questionnaire consisting of five subscales: hyperactivity, irritability, social withdrawal, stereotypic behavior and inappropriate speech in children with developmental disabilities. A higher score indicates more frequent aberrant behaviors. Our secondary measures are the subscale scores for Irritability (15 item), Social Withdrawal (16 item) and Hyperactivity (16 item). Each item rates behavior severity on a 4 point scale from 0 (Not at all a problem) to 3 (The problem is severe in degree). Total score ranges from 0 to 174. Lower scores are better.

The Parent-rated Anxiety Scale for Autism Spectrum Disorder is a 25-item scale that measures anxiety in youth with ASD. Each item rates the severity of a behavior on a 4 point scale from 0 (None/not present) to 3 (Severe/Very frequent and a major problem). The total score ranges from 0 to 75. Lower scores are better.

The Caregiver Strain short-form questionnaire is a 7-item measure of self-reported strain experienced by caregivers of children with behavioral disorders. Each item rates the severity of interference in the quality of the caregiver's life on a 5 point scale from 0 (Not at All) to 4 (Very Much). The scale ranges from 0 to 28. Lower scores are better.

The Vineland III Caregiver is a 381-item parent-reported measure of adaptive behavior in children with developmental and intellectual disabilities. The Vineland is comprised of three sub scores for the following domains: Communication, Daily Living Skills, and Socialization. The frequency of adaptive behaviors for each item is scored on a scale from 0 (Never) to 2 (Usually). The total adaptive score is reflected as a composite score of the sub domains (which is determined by age norms) in which a higher total score reflects higher functioning. The scale is standardized with a mean of 100 and standard deviation of 15.

Columbia-Suicide Severity Rating Scale: a suicide risk assessment that identifies presence and severity of suicidal ideation, planning, and behavior, as well as non-suicidal self-harm behaviors. Presence of any of these behaviors during the course of study enrollment will be considered an adverse event.

Differential Abilities Scale-II: cognitive abilities across core domains: verbal, nonverbal, spatial. Subtests: Verbal comprehension: 42-item domain, raw score 0-23. Naming vocabulary: 34-item domain, raw score 0-28. Word definitions: 35-item domain, raw score 0-25. Verbal similarities: 33-item domain, raw score 0-28. Picture similarities: 32-item domain, raw score 0-23. Picture similarities: 50-item domain, raw score 0-34. Matrices: 56-item domain, raw score 0-33. Pattern construction: 35-item domain, raw score 0-74. Copying: 20-item domain, raw score 0-36. Recall of designs: 22-item domain, raw score 0-43. All subdomains have a t-score range of 10-90. Verbal ability standard score ranges from 30-170. Nonverbal ability standard score ranges from 32-170. Spatial ability standard score ranges from 34-170. Total General Conceptual Ability standard score ranges from 30-170. Subtests and item sets given vary by participant age. Higher scores are better.