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NCT00585442 · ClinicalTrials.gov registry record · Early Phase 1
Effects of Vitamin D on Renin Expression in Hypertensive Patients
A Early Phase 1 study, sponsored by University of Utah.
- Terminated
- Registry status
- Early Phase 1
- Development phase
- 12
- Enrollment target
NCT00585442: Clinical Trial Early Phase 1 study, sponsored by University of Utah.
NCT00585442 is a Early Phase 1 study that was terminated before completion, run by University of Utah. The registered enrollment target is 12 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00585442, a Early Phase 1 study, was terminated before completion, sponsored by University of Utah.
- TERMINATED
- Registry status
- Early Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
The cardiovascular effects of vitamin D therapy (in humans) have been documented only in patients with known vitamin D deficiency or hyperparathyroidism (a surrogate marker of inadequate vitamin D activity). It is unknown whether the cardiovascular benefits of vitamin D therapy extend beyond these patients to the general hypertensive population. We propose to directly measure the effect of vitamin D therapy on plasma renin activity (PRA), plasma renin concentration (PRC), renin transcription (in mononuclear leukocytes), and blood pressure in hypertensive (but otherwise healthy) patients in a randomized, controlled, experimental trial. This will be the first study to assess vitamin D receptor (VDR) biological (PRA, PRC, renin mRNA, and polymorphisms) and hypertensive activity in patients without vitamin D deficiency. We hypothesize that vitamin D inhibition of renin transcription will produce significant reductions in PRA, PRC, renin transcription, inflammatory cytokines, SBP, and DBP, with potential variation by VDR genotype. Such a result may prove to be significant in the treatment of hypertension, as even modest blood pressure reductions (5 mmHg) are associated with a 14% reduction in mortality due to stroke, a 9% reduction in mortality due to CHD, and a 7% overall reduction in all-cause mortality.
Interventions
- DRUG Placebo
- DRUG calcitriol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2007-05 |
| Est. Completion | 2008-06 |
| Phase | Early Phase 1 |
Why NCT00585442 stopped before completion
NCT00585442 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00585442 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00585442 about?
NCT00585442 is a clinical study titled "Effects of Vitamin D on Renin Expression in Hypertensive Patients". The cardiovascular effects of vitamin D therapy (in humans) have been documented only in patients with known vitamin D deficiency or hyperparathyroidism (a surrogate marker of inadequate vitamin D activity). It is unknown whether the cardiovascular benefits of vitamin D therapy extend beyond these p...
What is the current status of trial NCT00585442?
This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 12 participants. The study started on 2007-05. Estimated completion is 2008-06.
What interventions are being tested in trial NCT00585442?
The interventions under investigation include: Placebo (DRUG), calcitriol (DRUG).
Who is sponsoring clinical trial NCT00585442?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00585442's enrollment target sits among peer trials
12 1529th of 2000 higher than 401 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early 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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