NCT03835117

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

Completed Phase 2 Results posted Last updated 9 May 2025

What this trial tests

Phase 2 trial testing Wide-spectrum nutritional supplement in Autism Spectrum Disorder in 16 participants. Completed in 31 July 2022.

Timeline

1 February 2020

Primary endpoint
31 July 2022

31 July 2022

Quick facts

Lead sponsor	Rossignol Medical Center
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	treatment
Enrollment	16
Start date	1 February 2020
Primary completion	31 July 2022
Estimated completion	31 July 2022
Sites	1 location across United States

Drugs / interventions tested

• Wide-spectrum nutritional supplement — full drug profile →
• Placebo

Conditions studied

• Autism Spectrum Disorder — all drugs for Autism Spectrum Disorder →

Sponsor

Rossignol Medical Center

Who can join

Adults 2 to 17, any sex, with Autism Spectrum Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Mitochondrial Activity in Study Patients: Citrate Synthase Primary · Before (Baseline), After Part I (Week 12), After Part 2 (Week 24)

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.

Before

Group	Value	95% CI
Wide-spectrum Nutritional Supplement	40.56	± 16.64
Placebo Control	29.09	± 11.48

After

Group	Value	95% CI
Wide-spectrum Nutritional Supplement	27.41	± 6.43
Placebo Control	37.78	± 16.89

Change in Mitochondrial Activity in Study Patients: Complex I Primary · Before (Baseline), After Part I (Week 12), After Part 2 (Week 24)

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.

Before

Group	Value	95% CI
Wide-spectrum Nutritional Supplement	2.88	± 1.37
Placebo Control	3.31	± 1.99

After

Group	Value	95% CI
Wide-spectrum Nutritional Supplement	2.98	± 1.65
Placebo Control	2.86	± 0.93

Change in Mitochondrial Activity in Study Patients: Complex II Primary · Before (Baseline), After Part I (Week 12), After Part 2 (Week 24)

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

Before

Group	Value	95% CI
Wide-spectrum Nutritional Supplement	0.10	± 0.06
Placebo Control	0.09	± 0.05

After

Group	Value	95% CI
Wide-spectrum Nutritional Supplement	0.09	± 0.06
Placebo Control	0.09	± 0.06

Change in Mitochondrial Activity in Study Patients: Complex IV Primary · Before (Baseline), After Part I (Week 12), After Part 2 (Week 24)

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.

Before

Group	Value	95% CI
Wide-spectrum Nutritional Supplement	0.18	± 0.04
Placebo Control	0.21	± 0.07

After

Group	Value	95% CI
Wide-spectrum Nutritional Supplement	0.22	± 0.04
Placebo Control	0.17	± 0.03

Change in the Childhood Autism Rating Scale (CARS) Score Secondary · Before (Baseline), After Part I (Week 12), After Part 2 (Week 24)

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 b

Before

Group	Value	95% CI
Wide-spectrum Nutritional Supplement	34.2	± 9.9
Placebo Control	37.2	± 6.8

After

Group	Value	95% CI
Wide-spectrum Nutritional Supplement	30.8	± 10.7
Placebo Control	32.2	± 3.4

Change in the Clinical Global Impression Scale (CGI) Score Secondary · Before (Baseline), After Part I (Week 12), After Part 2 (Week 24)

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.

Before

Group	Value	95% CI
Wide-spectrum Nutritional Supplement	4.5	± 1.3
Placebo Control	4.69	± 1.1

After

Group	Value	95% CI
Wide-spectrum Nutritional Supplement	4.31	± 1.4
Placebo Control	4.31	± 1.1

Change in the Children's Yale-Brown Obsessive Compulsive Scale Modified for Autism Spectrum Disorder (CYBOCS-ASD) Score Secondary · Before (Baseline), After Part I (Week 12), After Part 2 (Week 24)

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.

Before

Group	Value	95% CI
Wide-spectrum Nutritional Supplement	12.5	± 2.5
Placebo Control	12.9	± 2.4

After

Group	Value	95% CI
Wide-spectrum Nutritional Supplement	11.3	± 2.3
Placebo Control	11.9	± 2.3

Change in the Aberrant Behavior Checklist (ABC) Scores Secondary · Before (Baseline), After Part I (Week 12), After Part 2 (Week 24)

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 a

Before

Group	Value	95% CI
Wide-spectrum Nutritional Supplement	77.136	± 6.964
Placebo Control	79.859	± 6.964

After

Group	Value	95% CI
Wide-spectrum Nutritional Supplement	57.293	± 6.964
Placebo Control	73.87	± 6.964

Change in the Parent-rated Anxiety Scale for ASD (PRAS-ASD) Score Secondary · Before (Baseline), After Part I (Week 12), After Part 2 (Week 24)

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.

Before

Group	Value	95% CI
Wide-spectrum Nutritional Supplement	30.25	± 6.61
Placebo Control	23.18	± 6.61

After

Group	Value	95% CI
Wide-spectrum Nutritional Supplement	14.625	± 6.61
Placebo Control	26.1	± 6.61

Change in the Caregiver Strain Questionnaire (CGSQ) Score Secondary · Before (Baseline), After Part I (Week 12), After Part 2 (Week 24)

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.

Before

Group	Value	95% CI
Wide-spectrum Nutritional Supplement	18.25	± 2.695
Placebo Control	17.625	± 2.695

After

Group	Value	95% CI
Wide-spectrum Nutritional Supplement	11.5	± 2.695
Placebo Control	14.93	± 2.695

Change in the Vineland III Caregiver Score Secondary · Before (Baseline), After Part I (Week 12), After Part 2 (Week 24)

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 s

Before

Group	Value	95% CI
Wide-spectrum Nutritional Supplement	62.645	± 2.278
Placebo Control	65.199	± 2.278

After

Group	Value	95% CI
Wide-spectrum Nutritional Supplement	69.861	± 2.278
Placebo Control	62.175	± 2.278

Evaluate Intervention Safety Secondary · Screening, Baseline, After Week 4, After Week 8, After Week 12, Atter Week 16, After Week 20, After Week 24

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.

Group	Value	95% CI
Wide-spectrum Nutritional Supplement	0
Placebo Control	0

Adverse events — posted to ClinicalTrials.gov

Time frame: 24 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Wide-spectrum Nutritional Supplement

Serious: 0/16 (0%)

Deaths: 0/16

Placebo Control

Serious: 0/16 (0%)

Deaths: 0/16

Other adverse events (1 terms — click to expand)

Reaction	System	Wide-spectrum Nutritional …	Placebo Control
Mild transient constipation, diarrhea, and acid reflux	Gastrointestinal disorders	—	—

Data from ClinicalTrials.gov NCT03835117 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A Mitochondrial Supplement Improves Function and Mitochondrial Activity in Autism: A Double-Blind Placebo-Controlled Cross-Over Trial.
   Hill Z, McCarty PJ, Boles RG, Frye RE. · · 2025 · cited 4× · PMID 40141123 · DOI 10.3390/ijms26062479