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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 is a Phase 2 study that has completed, run by Arizona State University. The registered enrollment target is 120 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02059577
The ClinicalTrials.gov registry entry for NCT02059577 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Arizona State University, which has 187 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Nutritional and Dietary Interventions is the first listed.
NCT02059577 reports 0 study locations.
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.
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