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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: Completed Phase 2 study, sponsored by University of California, San Francisco.
NCT01535508 is a Phase 2 study that has completed, run by University of California, San Francisco. The registered enrollment target is 10 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Assessment of global changes in severity of autistic symptoms. CGI-I scores formulated by the clinician based on parent interview of changes in the child's behavior and from direct clinical observation, where scores of 0 = no improvement,1 = minimally improved, 2 = much improved, and 3 = very much improved.
Interventions
- DRUG Liquid Vitamin D
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2012-02 |
| Est. Completion | 2015-12 |
| Phase | Phase 2 |
What the finished NCT01535508 record still lists
NCT01535508 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which Liquid Vitamin D is the first listed.
NCT01535508 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01535508's enrollment target sits among peer trials
10 1968th of 2000 higher than 12 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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