Open Label Clinical Trial of Vitamin D in Children With Autism
Public ClinicalTrials.gov record NCT01535508. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Open Label Clinical Trial of Vitamin D Dosage Tolerability, and Effect on Behavioral Measures in Children With Autism
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01535508
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 10 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 3 Years to 8 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 31, 2012
- Primary completion
- Aug 31, 2015
- Completion
- Nov 30, 2015
- Last update posted
- Oct 8, 2019
2012 – 2015
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01535508, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 8, 2019 · Synced Sep 11, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01535508 live on ClinicalTrials.gov.