Autism Spectrum DisorderNCT04845776
Vitamin/Mineral Supplement for Children With Autism
A study testing ANRC Essentials Plus in people with Autism Spectrum Disorder, run by Arizona State University at 1 site in United States.
Trial summary
This is an open-label 3 month clinical trial of a vitamin/mineral supplement designed for children with autism. Read more about this study
- Who is it for?
- Ages 3 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- ANRC Essentials Plus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 4 May 2021to 22 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 3 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Child age 3-17 years (up until 18th birthday)
- Previous diagnosis of ASD by a psychiatrist, psychologist, or developmental pediatrician
- Verification of diagnosis by ASU staff using the Autism Diagnostic Interview-Revised.
- No changes in any medical, nutritional, dietary, behavior, or other treatment in the last three months, and a willingness to avoid any changes during the study
- Participant is able to wear a mask during the short visit for the blood draw.
Who cannot join
- Parent/guardian is unable to read or speak English fluently.
- Use of a vitamin/mineral supplement in the past 3 months
- Previous adverse reaction to a vitamin/mineral supplement
- Unstable, poor health; seizure disorder that is not responsive to treatment or not on stable management or complex type; or other health conditions that would significantly increase their risk of adverse effects (per physician clinical judgement)
- Use of any medication which has a contra-indication for one of the ingredients in the vitamin/mineral supplement
- A major single-gene disorder such as Fragile X, Down's Syndrome.
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- Major brain malformation
- Tube feeding
- Current participation in other clinical trials
- Females who are pregnant or who are sexually active without effective birth control.
- Clinically significant abnormalities at baseline on two blood safety tests: Comprehensive Metabolic Panel and Complete Blood Count with Differential.
- Psychotropic medication use which can affect neurotransmitter levels/function - Current or within past 2 months
Trial locations and contacts
1 site in 1 country.
About this study
This is an open-label 3 month clinical trial of a vitamin/mineral supplement designed for children with autism.
Read the detailed description
This is an open-label 3 month clinical trial of a vitamin/mineral supplement designed for children with autism. There will be pre/post assessments of autism symptoms,GI symptoms, and laboratory tests. Typically-developing children will be assessed at baseline only (no treatments) for comparison.
- Conditions
- Autism Spectrum Disorder
- Being tested
- ANRC Essentials Plus
- 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.
ANRC Essentials PlusDietary supplement
a vitamin/mineral supplement designed for children and adults with autism
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | This group receives the vitamin/mineral supplement, ANRC Essentials Plus, for 3 months Receives: Dietary Supplement: ANRC Essentials Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parent Global Impressions of Autism
a 20-item questionnaire with a Likert scale assessing changes in symptoms
Measured: assessed at the 3 months (end of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study start4 May 2021
- Primary completion19 Sep 2022
- Study completion22 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Arizona State UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All study participants with ASD will receive the vitamin/mineral supplement
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Collaborators
- Southwest College of Naturopathic Medicine
- Responsible party
- Sponsor
- Investigators
- James B Adams, PhD, Principal investigator, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04845776
- Sponsor's protocol ID
- STUDY00013694
- Status last verified
- Jan 2023
- First submitted
- 12 Apr 2021
- Last updated
- 9 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin/Mineral Supplement for Children With Autism
- ClinicalTrials.gov ID
- NCT04845776
- Acronym / sponsor ID
- STUDY00013694
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Collaborators
- Southwest College of Naturopathic Medicine
- Study start
- 4 May 2021 (actual)
- Primary completion
- 19 Sep 2022 (actual)
- Study completion
- 22 Sep 2022 (actual)
- First posted
- 15 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label 3 month clinical trial of a vitamin/mineral supplement designed for children with autism.
Detailed description
This is an open-label 3 month clinical trial of a vitamin/mineral supplement designed for children with autism. There will be pre/post assessments of autism symptoms,GI symptoms, and laboratory tests. Typically-developing children will be assessed at baseline only (no treatments) for comparison.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All study participants with ASD will receive the vitamin/mineral supplement
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Dietary Supplement: ANRC Essentials PlusThis group receives the vitamin/mineral supplement, ANRC Essentials Plus, for 3 months |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Child age 3-17 years (up until 18th birthday)
- Previous diagnosis of ASD by a psychiatrist, psychologist, or developmental pediatrician
- Verification of diagnosis by ASU staff using the Autism Diagnostic Interview-Revised.
- No changes in any medical, nutritional, dietary, behavior, or other treatment in the last three months, and a willingness to avoid any changes during the study
- Participant is able to wear a mask during the short visit for the blood draw.
Key exclusion criteria (12 listed)
- Parent/guardian is unable to read or speak English fluently.
- Use of a vitamin/mineral supplement in the past 3 months
- Previous adverse reaction to a vitamin/mineral supplement
- Unstable, poor health; seizure disorder that is not responsive to treatment or not on stable management or complex type; or other health conditions that would significantly increase their risk of adverse effects (per physician clinical judgement)
- Use of any medication which has a contra-indication for one of the ingredients in the vitamin/mineral supplement
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 |
|---|---|---|
| ANRC Essentials Plusa vitamin/mineral supplement designed for children and adults with autism | Dietary supplement | Treatment Group |
Primary outcome
Parent Global Impressions of Autism
Time frame: assessed at the 3 months (end of treatment)
a 20-item questionnaire with a Likert scale assessing changes in symptoms
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2023.
- website for our research groupLink provided by the sponsor.
- 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.
James B Adams, PhD principal investigator
Arizona State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ANRC Essentials Plus in people with Autism Spectrum Disorder, run by Arizona State University 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 5 inclusion and 12 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 9 Jan 2023. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Parent Global Impressions of Autism (time frame: assessed at the 3 months (end of treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jan 2023.