Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2026-04-10 @ 12:39 AM
Study NCT ID:
NCT02213094
Status:
COMPLETED
Last Update Posted:
2018-11-02
First Post:
2014-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase I Study of Nicotinamide for Early Onset Preeclampsia
Sponsor:
University of North Carolina, Chapel Hill
Organization:
Study Overview
Official Title:
Phase I Study of Nicotinamide for Early Onset Preeclampsia
Status:
COMPLETED
Status Verified Date:
2018-03
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 is a Phase I study of vitamin B3-amide (nicotinamide) dietary supplementation in pregnant women with early onset preeclampsia. The investigators will enroll 10 pregnant women at 24-32 weeks' gestation with the diagnosis of preeclampsia. If the woman is anticipated to remain undelivered for 48 hours after diagnosis she will receive vitamin B3-amide, 500 mg/day given in the morning (n=5) or 1000 mg given in the morning (n=5), continuing until delivery or for 14 days, whichever occurs first. Maternal blood will be collected at baseline and twice a day on days 1, 3, and 7 of nicotinamide administration to measure nicotinamide metabolites, The objectives of this Phase I study are to to test safety of nicotinamide.
Detailed Description:
None
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?: