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NCT01909115 · ClinicalTrials.gov registry record · Phase 1
Two Vitamin D Dosing Strategies in Children With Chronic Kidney Disease
A Phase 1 study, sponsored by Emory University.
- Completed
- Registry status
- Phase 1
- Development phase
- 98
- Enrollment target
NCT01909115: Completed Phase 1 study, sponsored by Emory University.
NCT01909115 is a Phase 1 study that has completed, run by Emory University. The registered enrollment target is 98 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01909115, a Phase 1 study, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 98 participants
- Enrollment target
Study Summary
Vitamin D deficiency is common in the general population and more common in children with chronic kidney disease. Vitamin D is very important for bone health, especially in children with chronic kidney disease. To date, several studies using different doses of vitamin D have been tried to correct vitamin D deficiency, but none has been completely successful. The investigators are comparing two different doses of vitamin D to determine which one is more effective at correcting and maintaining normal blood levels of vitamin D. The investigators hypothesize that a higher percentage of children receiving a higher dose of vitamin D will be vitamin D replete at the end of 6 months. This study will enroll 80 children 9 to 18 years old who have chronic kidney disease (CKD) and can take pills. They will be enrolled from Chronic Renal Insufficiency Clinic, the Hemodialysis Unit, Peritoneal Dialysis Clinic and Transplant Clinic at Children's Healthcare of Atlanta.
Primary Outcome
Vitamin D sufficiency will be assessed as the percentage of participants with a vitamin D level \>30 ng/ml.
Interventions
- DRUG 1000 IU of Vitamin D3
- DRUG 4000 IU of Vitamin D3
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 98 participants |
| Start Date | 2013-09 |
| Est. Completion | 2014-09-26 |
| Phase | Phase 1 |
What the finished NCT01909115 record still lists
NCT01909115 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 98 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% higher).
The record links to 0 conditions, and to 2 interventions - of which 1000 IU of Vitamin D3 is the first listed.
NCT01909115 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01909115 about?
NCT01909115 is a clinical study titled "Two Vitamin D Dosing Strategies in Children With Chronic Kidney Disease". Vitamin D deficiency is common in the general population and more common in children with chronic kidney disease. Vitamin D is very important for bone health, especially in children with chronic kidney disease. To date, several studies using different doses of vitamin D have been tried to correct vi...
What is the current status of trial NCT01909115?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 98 participants. The study started on 2013-09. Estimated completion is 2014-09-26.
What interventions are being tested in trial NCT01909115?
The interventions under investigation include: 1000 IU of Vitamin D3 (DRUG), 4000 IU of Vitamin D3 (DRUG).
Who is sponsoring clinical trial NCT01909115?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01909115's enrollment target sits among peer trials
98 592nd of 2000 higher than 1,404 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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