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NCT01601847 · ClinicalTrials.gov registry record · Phase 4
Wheezing in Black Preterm Infants: Impact of Vitamin D Supplementation Strategy
A Phase 4 study, sponsored by Case Western Reserve University.
- Completed
- Registry status
- Phase 4
- Development phase
- 300
- Enrollment target
NCT01601847: Completed Phase 4 study, sponsored by Case Western Reserve University.
NCT01601847 is a Phase 4 study that has completed, run by Case Western Reserve University. The registered enrollment target is 300 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01601847, a Phase 4 study, has completed, sponsored by Case Western Reserve University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 300 participants
- Enrollment target
Study Summary
The goal of this study is to identify a vitamin D supplementation strategy that best promotes the lung, immune, and overall health of black infants born preterm (28-36 weeks gestational age). This is a high risk population that seems to have unique vitamin D needs, and inappropriate supplementation may promote wheezing or allergy. The results of this study will help form nutritional recommendations for the approximately 100,000 black infants born at 30-36 weeks gestational age in the U.S. every year.
Primary Outcome
Recurrent wheezing was defined as more than 1 episode of wheezing reported during the study period. Separate episodes were defined as occurring at least 2 weeks apart.
Interventions
- DIETARY_SUPPLEMENT Cholecalciferol
- DRUG Cholecalciferol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2013-01 |
| Est. Completion | 2017-03-12 |
| Phase | Phase 4 |
What the finished NCT01601847 record still lists
NCT01601847 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (42% lower).
The record links to 0 conditions, and to 2 interventions - of which Cholecalciferol is the first listed.
NCT01601847 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01601847 about?
NCT01601847 is a clinical study titled "Wheezing in Black Preterm Infants: Impact of Vitamin D Supplementation Strategy". The goal of this study is to identify a vitamin D supplementation strategy that best promotes the lung, immune, and overall health of black infants born preterm (28-36 weeks gestational age). This is a high risk population that seems to have unique vitamin D needs, and inappropriate supplementation ...
What is the current status of trial NCT01601847?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 300 participants. The study started on 2013-01. Estimated completion is 2017-03-12.
What interventions are being tested in trial NCT01601847?
The interventions under investigation include: Cholecalciferol (DIETARY_SUPPLEMENT), Cholecalciferol (DRUG).
Who is sponsoring clinical trial NCT01601847?
This trial is sponsored by Case Western Reserve University, which has 141 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01601847's enrollment target sits among peer trials
300 269th of 2000 higher than 1,709 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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