AutismPhase 2NCT02059577
Nutritional and Dietary Treatment Study for Children/Adults With Autism
A Phase 2 study testing Nutritional and Dietary Interventions in people with Autism, run by Arizona State University at 1 site in United States.
Trial summary
70 children and adults with autism spectrum disorders will be enrolled in a 1-year, single-blind treatment study. Assessments will be conducted at the beginning and end of the study, including measurements of nutritional, metabolic, and digestive status and assessments of autism severity and overall functioning. Read more about this study
- Who is it for?
- Ages 30 months to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism
- What is being tested?
- Nutritional and Dietary Interventions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Apr 2013
- 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 30 months to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Diagnosis of autism spectrum disorder (autism, PDD-NOS, or Asperger's) by a psychiatrist, psychologist, or developmental pediatrician
- Verification of diagnosis by an ADOS evaluation (conducted by ASU staff)
- Age of 2.5 years to 60 years
- Enrollment Criteria - Non-autism Group
- No diagnosed mental disorders, including autism spectrum disorders, ADHD, depression, anxiety, etc.
- No first-degree relatives of individuals with autism (no siblings or parents)
- Age of 2.5 years to 60 years -
Who cannot join
- Major changes in behavioral or medical treatments in the previous two months, or intention to make such changes during the 12 months of the study.
- Usage of nutritional supplements (vitamins, minerals essential fatty acids, carnitine) or special diets in the previous two months
- Exclusion Criteria - Non-autism Group 1) Usage of nutritional supplements (vitamins, minerals essential fatty acids, carnitine) or special diets in the previous two months
- -
Trial locations and contacts
1 site in 1 country.
About this study
70 children and adults with autism spectrum disorders will be enrolled in a 1-year, single-blind treatment study. Assessments will be conducted at the beginning and end of the study, including measurements of nutritional, metabolic, and digestive status and assessments of autism severity and overall functioning. Half of the participants will be randomized into a treatment study, and half will be randomized to no changes in their current treatments. Treatments will be added in a sequential manner over 12 months, including vitamin/minerals, essential fatty acids, carnitine, digestive enzymes, and healthy, gluten-free, casein-free diets. A dedicated team of nutritionists, nurses, and physicians will support and monitor the participants throughout the study.
A group of 50 neurotypical children and adults, of similar age and gender, will be included for comparison.
- Conditions
- Autism
- Being tested
- Nutritional and Dietary Interventions
- Keywords
- vitamins, minerals, essential fatty acids, Epsom salts, carnitine, digestive enzymes, gluten-free casein-free diet
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional and Dietary InterventionsDietary supplement
Also called vitamin/mineral supplement, essential fatty acids, Epsom salt bath, carnitine
Day 0: Vitamin/Mineral supplementation begins. Day 30: Essential Fatty Acid supplementation begins. Day 60: Epsom Salt baths begin (2x/week) Day 90: Carnitine supplementation begins Day 180 Digestive Enzyme supplementation begins; Day 210: Healthy, casein-free, gluten-free diet is begun.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | This group received a combination of nutritional treatments, added sequentially, including vitamins/minerals, essential fatty acids, Epsom salt baths, carnitine, digestive enzymes, and healthy, gluten-free, casein-free diets. Receives: Dietary Supplement: Nutritional and Dietary Interventions |
| Non-Treatment Group | No intervention | This group did not have any significant changes in their treatments for 12 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Childhood Autism Rating Scale
Pre and post assessment of autism symptoms/severity
Measured: 12 months
Reynolds Intellectual Assessment Scales
Pre and post test of intellectual ability
Measured: 12 months
Vineland Adaptive Behavior Scale
Pre and post evaluation of adaptive behaviors
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2014 (estimated)
- Study startNov 2011
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Collaborators
- Autism Research Instittute
- Responsible party
- Sponsor
- Investigators
- James B. Adams, PhD, Principal investigator, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02059577
- Sponsor's protocol ID
- NutritionDietAutism
- Status last verified
- Feb 2014
- First submitted
- 7 Feb 2014
- Last updated
- 11 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional and Dietary Treatment Study for Children/Adults With Autism
- ClinicalTrials.gov ID
- NCT02059577
- Acronym / sponsor ID
- NutritionDietAutism
- Conditions
- Autism
- Keywords
- vitamins, minerals, essential fatty acids, Epsom salts, carnitine, digestive enzymes, gluten-free casein-free diet
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Collaborators
- Autism Research Instittute
- Study start
- Nov 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 11 Feb 2014 (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.
70 children and adults with autism spectrum disorders will be enrolled in a 1-year, single-blind treatment study. Assessments will be conducted at the beginning and end of the study, including measurements of nutritional, metabolic, and digestive status and assessments of autism severity and overall functioning. Half of the participants will be randomized into a treatment study, and half will be randomized to no changes in their current treatments. Treatments will be added in a sequential manner over 12 months, including vitamin/minerals, essential fatty acids, carnitine, digestive enzymes, and healthy, gluten-free, casein-free diets. A dedicated team of nutritionists, nurses, and physicians will support and monitor the participants throughout the study.
A group of 50 neurotypical children and adults, of similar age and gender, will be included for comparison.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Dietary Supplement: Nutritional and Dietary InterventionsThis group received a combination of nutritional treatments, added sequentially, including vitamins/minerals, essential fatty acids, Epsom salt baths, carnitine, digestive enzymes, and healthy, gluten-free, casein-free diets. |
| Non-Treatment Group | No intervention | –This group did not have any significant changes in their treatments for 12 months |
Who may qualify
- Ages
- 30 months to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Diagnosis of autism spectrum disorder (autism, PDD-NOS, or Asperger's) by a psychiatrist, psychologist, or developmental pediatrician
- Verification of diagnosis by an ADOS evaluation (conducted by ASU staff)
- Age of 2.5 years to 60 years
- Enrollment Criteria - Non-autism Group
- No diagnosed mental disorders, including autism spectrum disorders, ADHD, depression, anxiety, etc.
Key exclusion criteria (4 listed)
- Major changes in behavioral or medical treatments in the previous two months, or intention to make such changes during the 12 months of the study.
- Usage of nutritional supplements (vitamins, minerals essential fatty acids, carnitine) or special diets in the previous two months
- Exclusion Criteria - Non-autism Group 1) Usage of nutritional supplements (vitamins, minerals essential fatty acids, carnitine) or special diets in the previous two months
- -
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 |
|---|---|---|
| Nutritional and Dietary InterventionsAlso: vitamin/mineral supplement, essential fatty acids, Epsom salt bath, carnitineDay 0: Vitamin/Mineral supplementation begins. Day 30: Essential Fatty Acid supplementation begins. Day 60: Epsom Salt baths begin (2x/week) Day 90: Carnitine supplementation begins Day 180 Digestive Enzyme supplementation begins; Day 210: Healthy, casein-free, gluten-free diet is begun. | Dietary supplement | Treatment Group |
Primary outcome
Childhood Autism Rating Scale
Time frame: 12 months
Pre and post assessment of autism symptoms/severity
Reynolds Intellectual Assessment Scales
Time frame: 12 months
Pre and post test of intellectual ability
Vineland Adaptive Behavior Scale
Time frame: 12 months
Pre and post evaluation of adaptive behaviors
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 11 Feb 2014.
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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 Nutritional and Dietary Interventions 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 7 inclusion and 4 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 11 Feb 2014. 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?
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?
Childhood Autism Rating Scale (time frame: 12 months). The study lists 3 primary outcomes in all. 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 11 Feb 2014.