AutismPhase 2NCT01225198
Vitamin/Mineral Supplement for Children and Adults With Autism
A Phase 2 study testing Multi-Vitamin/Mineral Supplement in people with Autism, run by Arizona State University at 1 site in United States.
Trial summary
The investigators hypothesis is that a new, revised formulation of a vitamin/mineral supplement will result in: 1. improvement of nutritional status in some children/adults with autism, and 2. reduction of some of the symptoms of autism in some children Read more about this study
- Who is it for?
- Ages 3 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism
- What is being tested?
- Multi-Vitamin/Mineral Supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 143 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Feb 2009
- Phase
- Phase 2
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- age 3-60 years old;
- Autism Group: diagnosis of autism, pervasive developmental disorder/not otherwise specified (PDD/NOS), or Asperger's by a psychiatrist or similar professional
- Control Group: in good mental and physical health, and no siblings with autism spectrum disorders, and no evidence of Attention Deficit Disorder by parent report
Who cannot join
- Usage of a vitamin/mineral supplement in the last 2 months
- Current use of any chelation treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: New Vitamin/Mineral Supplement for Children and Adults With Autism - National Study
The investigators hypothesis is that a new, revised formulation of a vitamin/mineral supplement will result in:
- improvement of nutritional status in some children/adults with autism, and
- reduction of some of the symptoms of autism in some children
Read the detailed description
The major goal of this study is to determine the effect of this vitamin/mineral supplement on levels of vitamins, minerals, neurotransmitters, and biomarkers for nutritional deficiencies. The study design is a randomized, double-blind, placebo-controlled. Blood and urine measurements will be measured at the beginning of the study in children with autism and typical children. Then, the children with autism will be given the supplement or placebo for 12 weeks, and then their blood and urine will be re-measured.
- Conditions
- Autism
- Being tested
- Multi-Vitamin/Mineral Supplement, Liquid Placebo
- Keywords
- Vitamins, Minerals
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-Vitamin/Mineral SupplementDietary supplement
A broad-spectrum vitamin/mineral supplement designed for children and adults with autism
Liquid PlaceboOther
The placebo was formulated to look and taste like the intervention supplement. A small amount of beta-carotene was used for coloring. Natural cherry, citric acid, and a proprietary blend of natural flavors were used for flavoring to create a vitamin-like after-taste. Sucralose was used as a sweetener and the same preservatives were included (potassium sorbate, sodium benzoate).
| Study group | Role | What they receive |
|---|---|---|
| Placebo Group | Placebo comparator | Liquid placebo with identical packaging and flavoring to the real supplement. Receives: Other: Liquid Placebo |
| Vitamin/Mineral Supplement Group | Experimental | Multi-vitamin/mineral supplement designed for this study for children and adults with autism spectrum disorders. Receives: Dietary Supplement: Multi-Vitamin/Mineral Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxidative Stress
Level of Plasma Nitrotyrosine
Measured: Beginning of study (day 0)
Oxidative Stress
Level of plasma nitrotyrosine
Measured: End of Study (after 12 weeks of treatment)
Secondary outcomes (1)
Parent Global Impressions - Revised
The Average Change of the Parent Global Impressions (PGI-R) assessment tool.
Measured: End of study (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2010 (estimated)
- Study startMay 2008
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AutismStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Collaborators
- Autism Research Institute, Legacy Foundation
- Investigators
- James B. Adams, PhD, Principal investigator, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01225198
- Sponsor's protocol ID
- AutismVitaminStudy2008
- Status last verified
- Oct 2010
- First submitted
- 14 Sep 2010
- Last updated
- 20 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Adams JB, Audhya T, McDonough-Means S, Rubin RA, Quig D, Geis E, Gehn E, Loresto M, Mitchell J, Atwood S, Barnhouse S, Lee W. Effect of a vitamin/mineral supplement on children and adults with autism. BMC Pediatr. 2011 Dec 12;11:111. doi: 10.1186/1471-2431-11-111.
PubMed 22151477
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Vitamin/Mineral Supplement for Children and Adults With Autism - National Study
- ClinicalTrials.gov ID
- NCT01225198
- Acronym / sponsor ID
- AutismVitaminStudy2008
- Conditions
- Autism
- Keywords
- Vitamins, Minerals
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Collaborators
- Autism Research Institute, Legacy Foundation
- Study start
- May 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 20 Oct 2010 (estimated)
- 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.
The investigators hypothesis is that a new, revised formulation of a vitamin/mineral supplement will result in:
- improvement of nutritional status in some children/adults with autism, and
- reduction of some of the symptoms of autism in some children
Detailed description
The major goal of this study is to determine the effect of this vitamin/mineral supplement on levels of vitamins, minerals, neurotransmitters, and biomarkers for nutritional deficiencies. The study design is a randomized, double-blind, placebo-controlled. Blood and urine measurements will be measured at the beginning of the study in children with autism and typical children. Then, the children with autism will be given the supplement or placebo for 12 weeks, and then their blood and urine will be re-measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Group | Placebo comparator | Other: Liquid PlaceboLiquid placebo with identical packaging and flavoring to the real supplement. |
| Vitamin/Mineral Supplement Group | Experimental | Dietary Supplement: Multi-Vitamin/Mineral SupplementMulti-vitamin/mineral supplement designed for this study for children and adults with autism spectrum disorders. |
Who may qualify
- Ages
- 3 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- age 3-60 years old;
- Autism Group: diagnosis of autism, pervasive developmental disorder/not otherwise specified (PDD/NOS), or Asperger's by a psychiatrist or similar professional
- Control Group: in good mental and physical health, and no siblings with autism spectrum disorders, and no evidence of Attention Deficit Disorder by parent report
Key exclusion criteria (2 listed)
- Usage of a vitamin/mineral supplement in the last 2 months
- Current use of any chelation treatment
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 |
|---|---|---|
| Multi-Vitamin/Mineral SupplementA broad-spectrum vitamin/mineral supplement designed for children and adults with autism | Dietary supplement | Vitamin/Mineral Supplement Group |
| Liquid PlaceboThe placebo was formulated to look and taste like the intervention supplement. A small amount of beta-carotene was used for coloring. Natural cherry, citric acid, and a proprietary blend of natural flavors were used for flavoring to create a vitamin-like after-taste. Sucralose was used as a sweetener and the same preservatives were included (potassium sorbate, sodium benzoate). | Other | Placebo Group |
Primary outcome
Oxidative Stress
Time frame: Beginning of study (day 0)
Level of Plasma Nitrotyrosine
Oxidative Stress
Time frame: End of Study (after 12 weeks of treatment)
Level of plasma nitrotyrosine
1 secondary outcome
Parent Global Impressions - Revised
Time frame: End of study (12 weeks)
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 20 Oct 2010.
- Derived from this study: PubMed 22151477Adams JB, Audhya T, McDonough-Means S, Rubin RA, Quig D, Geis E, Gehn E, Loresto M, Mitchell J, Atwood S, Barnhouse S, Lee W. Effect of a vitamin/mineral supplement on children and adults with autism. BMC Pediatr. 2011 Dec 12;11:111. doi: 10.1186/1471-2431-11-111.
- Arizona State University Autism/Asperger's Research ProgramLink provided by the sponsor.
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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 Phase 2 study testing Multi-Vitamin/Mineral Supplement in people with Autism, 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 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 20 Oct 2010. 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?
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?
Oxidative Stress (time frame: Beginning of study (day 0)). 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 NCT01225198, which also lists 1 linked publication.
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 20 Oct 2010.