Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-27 @ 11:46 PM
Study NCT ID:
NCT01114360
Status:
COMPLETED
Last Update Posted:
2015-12-18
First Post:
2010-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Melatonin and Nighttime Blood Pressure in African Americans-8 mg Study
Sponsor:
Emory University
Organization:
Study Overview
Official Title:
Melatonin and Nighttime Blood Pressure in African Americans- 8 mg Study
Status:
COMPLETED
Status Verified Date:
2015-11
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:
This purpose of this study is to test the effect of oral melatonin supplementation (8 mg per night for 4 weeks) on nighttime blood pressure in African Americans with a history of elevated nighttime blood pressure.
Detailed Description:
The main outcome of interest is the mean nighttime blood pressure. The investigator is also trying to see the mechanism of action of melatonin on blood pressure by analyzing data from sleep studies to see if melatonin lowers blood pressure by providing a better quality of sleep or is that independent of the quality of sleep.
The investigator is also looking into the effect of melatonin on sympathetic nervous system by measuring urinary catecholamines.
Finally, the investigator is looking into changes in vascular biology markers (P-selectin and e-selectin) on melatonin.
The investigator is also looking into the effect of melatonin on sympathetic nervous system by measuring urinary catecholamines.
Finally, the investigator is looking into changes in vascular biology markers (P-selectin and e-selectin) on melatonin.
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 |
|---|---|---|---|---|
| 1R21AT004509-01A2 | NIH | None | https://reporter.nih.gov/quic… | View |