Ignite Creation Date:
2025-12-17 @ 3:50 PM
Ignite Modification Date:
2025-12-23 @ 10:50 PM
Study NCT ID:
NCT00736632
Status:
COMPLETED
Last Update Posted:
2020-02-10
First Post:
2008-08-15
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Vitamin D, Insulin Resistance, and Cardiovascular Disease
Sponsor:
Washington University School of Medicine
Organization:
Study Overview
Official Title:
Vitamin D, Insulin Resistance, and Cardiovascular Disease
Status:
COMPLETED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In recent years, vitamin D has been shown not only to be important for bone and calcium metabolism but also for homeostasis of critical tissues involved in vascular disease in patients with diabetes. Epidemiological studies indicated the high prevalence of vitamin D deficiency among Type 2 DM patients and suggest an increased risk of cardiovascular disease and hypertension with low vitamin D levels. The objective of this proposal is to evaluate the effects of vitamin D replacement on blood pressure control and vascular disease in vitamin D deficient hypertensive patients with diabetes
Detailed Description:
This is a double blinded, placebo controlled trial. Patients who meet the inclusion criteria will be randomized to placebo or 25(OH)D3, 4,000 IU/d orally for 16 weeks. Enrolled patients will be tested for 24h-blood pressure, brachial arterial blood flow, vascular inflammatory markers and macrophage inflammatory response to modified-lipoproteins at baseline, middle and at the end of the study.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R01HL094818 | NIH | None | https://reporter.nih.gov/quic… | View |