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Could a vitamin cocktail fix energy problems in autism?

NCT ID NCT03835117

Disease control Sponsor: Rossignol Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 30, 2026 · Last updated Jul 01, 2026 · Updated 1 time

Summary

This study tests whether a wide-spectrum nutritional supplement can improve mitochondrial function in children with autism spectrum disorder (ASD). Mitochondria are the energy factories in cells, and some children with ASD have abnormal mitochondrial activity. The trial enrolls children aged 4 to 14 with confirmed ASD and mitochondrial dysfunction, giving them either the supplement or a placebo for 26 weeks. Researchers measure changes in mitochondrial activity and autism symptoms.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
wide-spectrum nutritional supplement (NeuroNeeds: Spectrum Needs and Q Needs)
What this could lead to
If the supplement normalizes mitochondrial activity, it could point toward a dietary approach to support metabolism in children with autism.
What could go wrong
This is a small, early-phase trial with only 16 children, so results may not apply broadly. The supplement is a mix of many ingredients, making it hard to know which, if any, are responsible for effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

16 people

The number who actually took part.

Started

Feb 2020

Finished

Jul 2022

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

autism spectrum disorder inborn mitochondrial metabolism disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Autism spectrum disorder

Contacts and locations

Locations

  • Southwestern Research & Resource Center

    Phoenix, Arizona, 85016, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.