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NCT02059577 · ClinicalTrials.gov registry record · Phase 2
Nutritional and Dietary Treatment Study for Children/Adults With Autism
A Phase 2 study, sponsored by Arizona State University.
- Completed
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
NCT02059577: Completed Phase 2 study, sponsored by Arizona State University.
NCT02059577 is a Phase 2 study that has completed, run by Arizona State University. The registered enrollment target is 120 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (10% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02059577, a Phase 2 study, has completed, sponsored by Arizona State University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
Study 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. 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.
Primary Outcome
Pre and post assessment of autism symptoms/severity
Interventions
- DIETARY_SUPPLEMENT Nutritional and Dietary Interventions
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2011-11 |
| Est. Completion | 2013-04 |
| Phase | Phase 2 |
What the finished NCT02059577 record still lists
NCT02059577 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (10% lower).
The record links to 0 conditions, and to 1 intervention - of which Nutritional and Dietary Interventions is the first listed.
NCT02059577 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02059577 about?
NCT02059577 is a clinical study titled "Nutritional and Dietary Treatment Study for Children/Adults With Autism". 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...
What is the current status of trial NCT02059577?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2011-11. Estimated completion is 2013-04.
What interventions are being tested in trial NCT02059577?
The interventions under investigation include: Nutritional and Dietary Interventions (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT02059577?
This trial is sponsored by Arizona State University, which has 187 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02059577's enrollment target sits among peer trials
120 569th of 2000 higher than 1,383 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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