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NCT00752102 · ClinicalTrials.gov registry record · Phase 4
Vitamin D and Coronary Calcification Study
A Phase 4 study, sponsored by Joslin Diabetes Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 44
- Enrollment target
NCT00752102: Completed Phase 4 study, sponsored by Joslin Diabetes Center.
NCT00752102 is a Phase 4 study that has completed, run by Joslin Diabetes Center. The registered enrollment target is 44 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00752102, a Phase 4 study, has completed, sponsored by Joslin Diabetes Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 44 participants
- Enrollment target
Study Summary
Patients with chronic kidney disease (CKD) have a higher mortality rate than the general population, with cardiovascular disease (CVD) accounting for approximately 50% of deaths. Vascular calcification is a common finding in patients with CKD. Furthermore, patients with CKD develop secondary hyperparathyroidism, partly because of a decrease of calcitriol synthesis on the kidney. Treatment of secondary hyperparathyroidism includes use of activated vitamin D including calcitriol and paricalcitol. Recent evidence in dialysis patients suggest an improved survival in patients using paricalcitol compared to calcitriol. Studies in uremic rats suggests that there are differential effects of calcitriol and paricalcitol in expression of markers of soft-tissue calcification independent of calcium-phosphorus product. Calcitriol increased calcification of vascular smooth muscle cells cultured in calcification media. There was also significant increase in pulse pressure in animals treated with calcitriol. The investigators hypothesize that these different forms of vitamin D may have differential effects in vascular calcification progression in CKD patients.
Primary Outcome
coronary artery (CAC) score difference between baseline and followup CT scans. It was measured in Agatston units. These are units of amount of calcification in the blood vessels so it's a continuous variable. The amount of calcium was quantified with the Agatston scoring method. Calcium scores were adjusted with a standard calcium phantom that was scanned along with the participant. The phantom contained known calcium density bars and provided a way to calibrate the x-ray attenuation level. Par
Interventions
- DRUG Paricalcitol
- DRUG Calcitriol (Rocaltrol®)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2008-09 |
| Est. Completion | 2013-10 |
| Phase | Phase 4 |
What the finished NCT00752102 record still lists
NCT00752102 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 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Paricalcitol is the first listed.
NCT00752102 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00752102 about?
NCT00752102 is a clinical study titled "Vitamin D and Coronary Calcification Study". Patients with chronic kidney disease (CKD) have a higher mortality rate than the general population, with cardiovascular disease (CVD) accounting for approximately 50% of deaths. Vascular calcification is a common finding in patients with CKD. Furthermore, patients with CKD develop secondary hyperpa...
What is the current status of trial NCT00752102?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 44 participants. The study started on 2008-09. Estimated completion is 2013-10.
What interventions are being tested in trial NCT00752102?
The interventions under investigation include: Paricalcitol (DRUG), Calcitriol (Rocaltrol®) (DRUG).
Who is sponsoring clinical trial NCT00752102?
This trial is sponsored by Joslin Diabetes Center, which has 73 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00752102's enrollment target sits among peer trials
44 1363rd of 2000 higher than 630 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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