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NCT01230307 · ClinicalTrials.gov registry record · Phase 4
Vitamin D Supplementation for Treatment of Heart Failure
A Phase 4 study, sponsored by University of Michigan.
- Terminated
- Registry status
- Phase 4
- Development phase
- 28
- Enrollment target
NCT01230307: Clinical Trial Phase 4 study, sponsored by University of Michigan.
NCT01230307 is a Phase 4 study that was terminated before completion, run by University of Michigan. The registered enrollment target is 28 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01230307, a Phase 4 study, was terminated before completion, sponsored by University of Michigan.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 28 participants
- Enrollment target
Study Summary
The central objective of this proposal is to establish that vitamin D supplementation in heart failure patients with low vitamin D levels will have improved outcomes compared to placebo. In addition the investigators will also evaluate the role of genetics in regard to vitamin D and heart failure. The investigators will be evaluating what is currently a novel approach of identifying patients with low vitamin D and treating this low vitamin D level. The investigators will be able to evaluate the importance of vitamin D supplementation in these patients and the role of genetics on our defined outcomes.
Primary Outcome
Biomarkers - C-reactive protein (CRP), interleukin-6 (IL-6), tumor necrosis factor-a (TNF-a), propeptide procollagen type I, plasma procollagen III, matrix metalloproteinase 2 (MMP-2), MMP-9 and tissue inhibitor of matrix metalloproteinases-1 (TIMP-1).
Interventions
- DRUG Placebo
- DRUG Vitamin D3
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2010-10 |
| Est. Completion | 2014-12 |
| Phase | Phase 4 |
Why NCT01230307 stopped before completion
NCT01230307 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01230307 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01230307 about?
NCT01230307 is a clinical study titled "Vitamin D Supplementation for Treatment of Heart Failure". The central objective of this proposal is to establish that vitamin D supplementation in heart failure patients with low vitamin D levels will have improved outcomes compared to placebo. In addition the investigators will also evaluate the role of genetics in regard to vitamin D and heart failure. T...
What is the current status of trial NCT01230307?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 28 participants. The study started on 2010-10. Estimated completion is 2014-12.
What interventions are being tested in trial NCT01230307?
The interventions under investigation include: Placebo (DRUG), Vitamin D3 (DRUG).
Who is sponsoring clinical trial NCT01230307?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01230307's enrollment target sits among peer trials
28 1635th of 2000 higher than 350 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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