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NCT01360476 · ClinicalTrials.gov registry record · NA
Vitamin D Therapy to Reduce Cardiac Damage Among Vulnerable Hypertensive Patients
A NA study, sponsored by Wayne State University.
- Completed
- Registry status
- NA
- Development phase
- 354
- Enrollment target
NCT01360476: Completed NA study, sponsored by Wayne State University.
NCT01360476 is a NA study that has completed, run by Wayne State University. The registered enrollment target is 354 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01360476, a NA study, has completed, sponsored by Wayne State University.
- COMPLETED
- Registry status
- NA
- Development phase
- 354 participants
- Enrollment target
Study Summary
This project seeks to reduce the disparity in hypertensive heart disease which exists for African-Americans who have poorly controlled hypertension (HTN), also known as blood pressure (BP). The investigators are targeting a highly vulnerable, often neglected subject population which stands to benefit tremendously from better BP control and a corresponding decrease in heart damage. HTN occurs early in life and more often in African-Americans, reducing both quality and quantity of life. Inner-city African-Americans with HTN utilize the emergency department (ED) for chronic BP management. Like cardiovascular disease, vitamin D deficiency disproportionately affects African-Americans. Vitamin D is thought to play an important role in cardiovascular health. Vitamin D replacement in those who are deficient has been thought to reduce the cardiovascular disease, especially if initiated early before irreversible damage has occurred, but this has yet to be tested in a prospective clinical trial. Accordingly, this proposal was designed to investigate the relationship between vitamin D and cardiac damage (as identified on cardiac magnetic resonance imaging) in a cohort of African-American, vitamin D deficient hypertensive patients without prior history of heart disease. The primary objective of this proposal is to evaluate the efficacy of vitamin D therapy in vitamin D deficient African-Americans with HTN. Vitamin D is an inexpensive treatment, which, if shown to be effective could improve the existing approach to a widely accessible, cost-effective option.
Primary Outcome
Cardiac MRI will be used to assess this change.
Interventions
- DIETARY_SUPPLEMENT Placebo
- DIETARY_SUPPLEMENT cholecalciferol (Vitamin D)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 354 participants |
| Start Date | 2011-08 |
| Est. Completion | 2015-11 |
| Phase | NA |
What the finished NCT01360476 record still lists
NCT01360476 is an interventional study that assigns participants to a tested intervention. The registered 354 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01360476 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01360476 about?
NCT01360476 is a clinical study titled "Vitamin D Therapy to Reduce Cardiac Damage Among Vulnerable Hypertensive Patients". This project seeks to reduce the disparity in hypertensive heart disease which exists for African-Americans who have poorly controlled hypertension (HTN), also known as blood pressure (BP). The investigators are targeting a highly vulnerable, often neglected subject population which stands to benefi...
What is the current status of trial NCT01360476?
This trial is currently completed. It is a NA study. The enrollment target is 354 participants. The study started on 2011-08. Estimated completion is 2015-11.
What interventions are being tested in trial NCT01360476?
The interventions under investigation include: Placebo (DIETARY_SUPPLEMENT), cholecalciferol (Vitamin D) (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01360476?
This trial is sponsored by Wayne State University, which has 163 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01360476's enrollment target sits among peer trials
354 291st of 2000 higher than 1,709 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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