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Autism Spectrum DisorderPhase 2NCT03835117

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

A Phase 2 study testing Wide-spectrum nutritional supplement in people with Autism Spectrum Disorder, run by Rossignol Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 2 to 17 years
Conditions the study is for
Autism Spectrum Disorder
What is being tested?
Wide-spectrum nutritional supplement
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
16 participants
Where
1 siteUnited States
Study dates
1 Feb 2020to 31 Jul 2022
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Southwestern Research & Resource Center

    Phoenix, Arizona, 85016

Other trials in United States

About this study

Official title: Effect of a Wide Spectrum Nutritional Supplement on Mitochondrial Function in Children With Autism Spectrum Disorder (ASD)

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.

Read the 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 Disease Control estimates that ASD affects as many as 17 per 1000 children (1 in 59) in the United States suggesting that the prevalence is higher than previous estimates.Despite the dramatic rise in the detected prevalence of ASD over the past two decades, there is no effective medical treatment for core ASD symptoms (social communication and repetitive behavior), the closely associated problem of language impairment, or the underlying pathophysiology of ASD. Currently, the only accepted treatment for core ASD symptoms is behavior therapy, which may entail intensive one-on-one treatment over several years.

The primary aims of this study are to evaluate the effect of a wide-spectrum nutritional supplement on mitochondrial function in individuals with ASD. Participants entered into the trial will have abnormalities in mitochondrial function that are known to be associated with ASD (approximately 50+% of children with ASD) but are not diagnostic of mitochondrial disease. The investigators hypothesize that nutritional supplements designed for children with ASD have a physiological action of normalizing mitochondrial function and cellular physiology throughout the body.

To test whether the targeted nutritional supplement is superior to placebo, the investigators will study 50 children, between the ages of 4 years to 14 years, with confirmed ASD and known abnormal variations in mitochondrial at baseline. Participants will be randomly assigned to receive active treatment or placebo for 12-weeks under double-blind conditions and at the end of the 12 weeks switch to the opposite condition after *no wash out period. Mitochondrial function will be measured at baseline and after each treatment arm in order to determine if the supplement positively influences cellular biochemistry. The investigator will also evaluate the effectiveness of the supplement on core and associated ASD symptoms using several behaviors assessments.

*note: 2 week wash out period was eliminated from the design to prevent attrition before the study was started. The CT.gov record was not updated for this change in the protocol in a timely manner. Published paper reflects the no wash out period. CT record is being updated for clarity. .

Being tested
Wide-spectrum nutritional supplement, Placebo
Keywords
Mitochondrial Dysfunction
Medical subject headings
Autism Spectrum Disorder, Mitochondrial Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Wide-spectrum nutritional supplementDrug

    Also called NeuroNeeds: Spectrum Needs, NeuroNeeds:Q Needs

    Comprehensive powder with 33 dietary supplements and 1 dietary supplement via gel capsule.

  • PlaceboOther

    Inactive placebo comparator

Study groups in NCT03835117
Study groupRoleWhat they receive
Wide-spectrum nutritional supplementExperimentalThe Wide-spectrum nutritional supplement used will be a combination of NeuroNeeds: SpectrumNeeds and QNeeds. Weight based dosing will be used. The daily serving size will be divided into two oral daily doses in the form of a powder which can be mixed into liquid or food. Together, there are 34 different dietary supplements in the products. Except for ubiquinol, all of these nutrients are provided in a powder form in SpectrumNeeds. Ubiquinol is provided separately in QNeeds gel capsules. These capsules can be swallowed whole, or cut with scissors and the contents squeezed out and added to SpectrumNeeds just before ingestion.
Receives: Drug: Wide-spectrum nutritional supplement
Placebo controlPlacebo comparatorParticipants randomized to receive placebo will take placebo in an oral form divided into powder and a gel capsule in the same manner as treatment. For the second phase of the cross over, participants will be part of the opposite group they were assigned to in Phase I (Placebo or Treatment). Quantities for placebo or treatment will match across phases for each subject, utilizing the same weight based dosing.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Mitochondrial Activity in Study Patients: Citrate Synthase

    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.

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

  2. Change in Mitochondrial Activity in Study Patients: Complex I

    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.

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

  3. Change in Mitochondrial Activity in Study Patients: Complex II

    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

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

  4. Change in Mitochondrial Activity in Study Patients: Complex IV

    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.

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

Secondary outcomes (9)

  1. Change in the Childhood Autism Rating Scale (CARS) Score

    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.

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

  2. Change in the Clinical Global Impression Scale (CGI) Score

    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.

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

  3. Change in the Children's Yale-Brown Obsessive Compulsive Scale Modified for Autism Spectrum Disorder (CYBOCS-ASD) Score

    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.

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

  4. Change in the Aberrant Behavior Checklist (ABC) Scores

    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.

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

  5. Change in the Parent-rated Anxiety Scale for ASD (PRAS-ASD) Score

    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.

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

  6. Change in the Caregiver Strain Questionnaire (CGSQ) Score

    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.

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

  7. Change in the Vineland III Caregiver Score

    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.

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

  8. Evaluate Intervention Safety

    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.

    Measured: Screening, Baseline, After Week 4, After Week 8, After Week 12, Atter Week 16, After Week 20, After Week 24

  9. Examine the Change in Cognitive Ability

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2019
  2. Study start1 Feb 2020
  3. Primary completion31 Jul 2022
  4. Study completion31 Jul 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
Prospective Randomized 12-week Double-Blind Placebo-Controlled Cross-over
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03835117
Sponsor's protocol ID
MITO
Status last verified
Jun 2026
First submitted
5 Feb 2019
Last updated
30 Jun 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Delhey LM, Nur Kilinc E, Yin L, Slattery JC, Tippett ML, Rose S, Bennuri SC, Kahler SG, Damle S, Legido A, Goldenthal MJ, Frye RE. The Effect of Mitochondrial Supplements on Mitochondrial Activity in Children with Autism Spectrum Disorder. J Clin Med. 2017 Feb 13;6(2):18. doi: 10.3390/jcm6020018.

    PubMed 28208802

  • Rose S, Niyazov DM, Rossignol DA, Goldenthal M, Kahler SG, Frye RE. Clinical and Molecular Characteristics of Mitochondrial Dysfunction in Autism Spectrum Disorder. Mol Diagn Ther. 2018 Oct;22(5):571-593. doi: 10.1007/s40291-018-0352-x.

    PubMed 30039193

  • Frye RE, Rossignol DA. Treatments for biomedical abnormalities associated with autism spectrum disorder. Front Pediatr. 2014 Jun 27;2:66. doi: 10.3389/fped.2014.00066. eCollection 2014.

    PubMed 25019065

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Wide-spectrum nutritional supplement in people with Autism Spectrum Disorder, run by Rossignol Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Mitochondrial Activity in Study Patients: Citrate Synthase (time frame: Before (Baseline), After Part I (Week 12), After Part 2 (Week 24)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03835117, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.

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Clinical Trial NCT03835117 | AzTrials