Autism Spectrum DisorderPhase 2NCT05268744

Micronutrient Supplementation in Children With ASD

A Phase 2 study testing Micronutrient in people with Autism Spectrum Disorder, run by University of California, San Francisco 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

An open-label examination of changes in metabolites with use of micronutrients in children with autism spectrum disorder (ASD). Investigators will also measure behavioral measures monthly at school with teachers and parents report. Read more about this study

Who is it for?: Ages 5 to 22 years
Conditions the study is for: Autism Spectrum Disorder
What is being tested?: Micronutrient
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteUnited States
Study dates: 14 Nov 2022to 30 Jan 2023
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 5 to 22 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Male or female, enrolled at Oak Hill School (OHS), age 6-22 and with a diagnosis of ASD.
ASD diagnosis will be established by standard criteria (DSM-IV criteria and expert clinician review of medical records and child observation).
Written informed consent obtained from the subject's legal representative and ability for subject to comply with the requirements of the study.

Who cannot join

Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
Taking multivitamins currently and unwilling to stop during the study period

Trial locations and contacts

1 site in 1 country.

United States1 site

University of California, San Francisco
San Francisco, California, 94143

Other trials in United States

About this study

Official title: Micronutrient Supplementation in Children With Autism Spectrum Disorder (ASD): A Clinical Trial Examining Mechanism of Action

Read the detailed description

Children enrolled in Oak Hill School will enroll in this study and take micronutrient supplement once a day for 8 weeks period. Behavioral measures and metabolites taken from Dried Blood Spots (DBS) will be collected pre and post treatment. Behavioral measures will be taken again at 12 weeks, after 4 weeks of not dosing.

Conditions: Autism Spectrum Disorder
Being tested: Micronutrient
Medical subject headings: Autism Spectrum Disorder

What participants receive

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

MicronutrientDrug
Subject will take micronutrient supplement daily for 8 weeks

Study groups in NCT05268744
Study group	Role	What they receive
Micronutrient	Experimental	In this open-label trial, all subjects will receive the daily dose of micronutrient, in the form of one lightning stick per day, which contains 2.9 grams of micronutrients per stick. It will be delivered in a powder form taken sublingually. Receives: Drug: Micronutrient

What is being measured

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

Change in the Autism Behavior Inventory, Short Form (ABI-S)
The ABI-S is an observer-reported outcome scale designed specifically to measure change and severity of Autism Spectrum Disorder (ASD) symptoms. ABI-S will be measured by both parents and teachers. There are 24 questions. The scoring of ABI-S questions can range from 0-3 (with possible reverse scoring) based on scoring instructions for data analysis. The total range of score is between 0 and 72. Lower score indicates better performance.
Measured: Baseline to Week 8
Change in the Social Responsiveness Scale (SRS)
SRS measures social ability in children and young adults. SRS will be measured by both parents and teachers. There are 65 questions. The scoring of SRS questions can range from 0-3 (with possible reverse scoring) based on scoring instructions for data analysis. The total possible score range for the SRS is 0 - 195. Lower score indicates better performance.
Measured: Baseline to Week 8

Timeline

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

14 Nov 202230 Jan 2023

First posted7 Mar 2022
Study start14 Nov 2022
Primary completion14 Jan 2023
Study completion30 Jan 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
More trials run by University of California, San FranciscoThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05268744
Sponsor's protocol ID: 22-35971
Status last verified: Jan 2024
First submitted: 24 Feb 2022
Last updated: 29 Feb 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Autism Spectrum Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Micronutrient Supplementation in Children With Autism Spectrum Disorder (ASD): A Clinical Trial Examining Mechanism of Action
ClinicalTrials.gov ID: NCT05268744
Acronym / sponsor ID: 22-35971
Conditions: Autism Spectrum Disorder
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: University of California, San FranciscoUniversity, hospital or other
Study start: 14 Nov 2022 (actual)
Primary completion: 14 Jan 2023 (actual)
Study completion: 30 Jan 2023 (actual)
First posted: 7 Mar 2022 (actual)
Results: Posted 29 Feb 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Micronutrient	Experimental	Drug: MicronutrientIn this open-label trial, all subjects will receive the daily dose of micronutrient, in the form of one lightning stick per day, which contains 2.9 grams of micronutrients per stick. It will be delivered in a powder form taken sublingually.

Who may qualify

Ages: 5 to 22 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (3 listed)

Male or female, enrolled at Oak Hill School (OHS), age 6-22 and with a diagnosis of ASD.
ASD diagnosis will be established by standard criteria (DSM-IV criteria and expert clinician review of medical records and child observation).
Written informed consent obtained from the subject's legal representative and ability for subject to comply with the requirements of the study.

Key exclusion criteria (2 listed)

Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
Taking multivitamins currently and unwilling to stop during the study period

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MicronutrientSubject will take micronutrient supplement daily for 8 weeks	Drug	Micronutrient

Primary outcome

Change in the Autism Behavior Inventory, Short Form (ABI-S)
Time frame: Baseline to Week 8
The ABI-S is an observer-reported outcome scale designed specifically to measure change and severity of Autism Spectrum Disorder (ASD) symptoms. ABI-S will be measured by both parents and teachers. There are 24 questions. The scoring of ABI-S questions can range from 0-3 (with possible reverse scoring) based on scoring instructions for data analysis. The total range of score is between 0 and 72. Lower score indicates better performance.
Change in the Social Responsiveness Scale (SRS)
Time frame: Baseline to Week 8
SRS measures social ability in children and young adults. SRS will be measured by both parents and teachers. There are 65 questions. The scoring of SRS questions can range from 0-3 (with possible reverse scoring) based on scoring instructions for data analysis. The total possible score range for the SRS is 0 - 195. Lower score indicates better performance.

Results and safety

Results posted to the registry on 29 Feb 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Participants	16	11

Primary outcome: Change in the Autism Behavior Inventory, Short Form (ABI-S)

Time frame: Baseline to Week 8. Mean (95% Confidence Interval). Unit: score on a scale

Measure	All Participants n = 11
ABI-S (Parent)	-2.9 (-7.1 to 1.4)
ABI-S (Teacher)	-0.8 (-4.4 to 2.8)

All Participants: p <0.05, t-test, 1 sided

Primary outcome: Change in the Social Responsiveness Scale (SRS)

Time frame: Baseline to Week 8. Mean (95% Confidence Interval). Unit: score on a scale

Measure	All Participants n = 11
SRS (Parent)	-8.1 (-18.4 to 2.2)
SRS (Teacher)	0.8 (-9.8 to 11.4)

Adverse events

Time frame: 8 Weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Study Participants	0 of 16 (0%)	0 of 16 (0%)	0 of 16

Limitations and caveats (from the sponsor): The limited sample size (N=11) has indeed constrained the statistical power of the analysis. The absence of a control group prevents direct comparisons between treated participants and untreated individuals, limiting our ability to isolate the effects of the micronutrient supplement from other confounding factors. We do not have information regarding the types of diets the participants were on which could have influenced their response to the micronutrient supplementation.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Robert Hendren, DO principal investigator

University of California, San Francisco

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Micronutrient in people with Autism Spectrum Disorder, run by University of California, San Francisco 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 3 inclusion and 2 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 29 Feb 2024. 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. 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 29 Feb 2024). 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 the Autism Behavior Inventory, Short Form (ABI-S) (time frame: Baseline to Week 8). The study lists 2 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 NCT05268744.

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 29 Feb 2024.