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NCT01092338 · ClinicalTrials.gov registry record · Phase 2
Vitamin D Dose Finding Study
A Phase 2 study of HIV Infections and AIDS, sponsored by Children's Hospital of Philadelphia.
- Completed
- Registry status
- Phase 2
- Development phase
- 44
- Enrollment target
- 1
- Study location
NCT01092338: Completed Phase 2 study of HIV Infections and AIDS, sponsored by Children's Hospital of Philadelphia.
NCT01092338 is a Phase 2 study of HIV Infections and AIDS that has completed, run by Children's Hospital of Philadelphia. The registered enrollment target is 44 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01092338, a Phase 2 study of HIV Infections and AIDS, has completed, sponsored by Children's Hospital of Philadelphia.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 44 participants
- Enrollment target
- 1
- Study location
Study Summary
Optimal vitamin D (vit D) concentration and metabolism are essential for normal immune function, growth, muscle, bone, and inflammatory status in children, adolescents and adults with HIV/AIDS. The impact of vit D supplementation will be evaluated for safety and efficacy using clinically important outcomes, and this will overcome the critical barrier for use of vit D supplementation in research and clinical care. Inexpensive and easy to administer, vit D supplementation may prove to be an effective and feasible treatment for symptoms and prevention of side effects for people of all ages living with HIV/AIDS in the US and around the world.
Primary Outcome
Determined by incidence of elevated serum calcium (above age specific range) associated with elevated serum 25D concentrations (\>160ng/ml).
Conditions Studied
Interventions
- DRUG Cholecalciferol (Vit D3)
Study Locations (1)
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2010-01 |
| Est. Completion | 2011-01 |
| Phase | Phase 2 |
What the finished NCT01092338 record still lists
NCT01092338 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (90% lower).
The record links to 2 conditions, with HIV Infections appearing as the primary indexed condition, and to 1 intervention - of which Cholecalciferol (Vit D3) is the first listed.
NCT01092338 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT01092338 about?
NCT01092338 is a clinical study titled "Vitamin D Dose Finding Study". Optimal vitamin D (vit D) concentration and metabolism are essential for normal immune function, growth, muscle, bone, and inflammatory status in children, adolescents and adults with HIV/AIDS. The impact of vit D supplementation will be evaluated for safety and efficacy using clinically important o...
What is the current status of trial NCT01092338?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 44 participants. The study started on 2010-01. Estimated completion is 2011-01.
What conditions does trial NCT01092338 study?
This clinical trial studies the following conditions: HIV Infections, AIDS.
What interventions are being tested in trial NCT01092338?
The interventions under investigation include: Cholecalciferol (Vit D3) (DRUG).
Who is sponsoring clinical trial NCT01092338?
This trial is sponsored by Children's Hospital of Philadelphia, which has 431 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01092338 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for HIV Infections
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01092338's enrollment target sits among peer trials
44 380th of 542 higher than 159 of 542 other HIV Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infections 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.
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