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NCT01535508 · ClinicalTrials.gov registry record · Phase 2
Open Label Clinical Trial of Vitamin D in Children With Autism
A Phase 2 study, sponsored by University of California, San Francisco.
- Completed
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
NCT01535508 is a Phase 2 study that has completed, run by University of California, San Francisco. The registered enrollment target is 10 participants.
The verdict
NCT01535508, a Phase 2 study, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
Study Summary
Primary: to investigate tolerability of interventional high dose Vitamin D3 supplementation, titrated to reach serum levels near the high end of the reference range (30-100 ng/ml), in vitamin D deficient pediatric Autism Spectrum Disorder (ASD) patients. The study will determine if initial safety and effect estimates predict that a double blind randomized control trial (RCT) with a larger set of patients will be worthwhile in the localization of this treatment aimed at improving the symptoms of ASDs. Exploratory: to determine efficacy of high dose D3 replacement for improvement in the core symptoms of autism, including sociability, eye contact, anger outbursts, stimming behavior, and sleep, as determined by parental and clinical evaluation scales.
Interventions
- DRUG Liquid Vitamin D
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2012-02 |
| Est. Completion | 2015-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01535508
The ClinicalTrials.gov registry entry for NCT01535508 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Liquid Vitamin D is the first listed.
NCT01535508 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01535508 about?
NCT01535508 is a clinical study titled "Open Label Clinical Trial of Vitamin D in Children With Autism". Primary: to investigate tolerability of interventional high dose Vitamin D3 supplementation, titrated to reach serum levels near the high end of the reference range (30-100 ng/ml), in vitamin D deficient pediatric Autism Spectrum Disorder (ASD) patients. The study will determine if initial safety a...
What is the current status of trial NCT01535508?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2012-02. Estimated completion is 2015-12.
What interventions are being tested in trial NCT01535508?
The interventions under investigation include: Liquid Vitamin D (DRUG).
Who is sponsoring clinical trial NCT01535508?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
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