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NCT02213094 · ClinicalTrials.gov registry record · Phase 1
Phase I Study of Nicotinamide for Early Onset Preeclampsia
A Phase 1 study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT02213094 is a Phase 1 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 10 participants.
The verdict
NCT02213094, a Phase 1 study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study 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.
Interventions
- DRUG Nicotinamide 500 mg
- DRUG Nicotinamide 1000 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2014-01-01 |
| Est. Completion | 2015-12-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02213094
The ClinicalTrials.gov registry entry for NCT02213094 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Nicotinamide 500 mg is the first listed.
NCT02213094 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02213094 about?
NCT02213094 is a clinical study titled "Phase I Study of Nicotinamide for Early Onset Preeclampsia". 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 h...
What is the current status of trial NCT02213094?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2014-01-01. Estimated completion is 2015-12-03.
What interventions are being tested in trial NCT02213094?
The interventions under investigation include: Nicotinamide 500 mg (DRUG), Nicotinamide 1000 mg (DRUG).
Who is sponsoring clinical trial NCT02213094?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
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