CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 10 enrolled
Drug / intervention
Nicotinamide 500 mg +1 moredrug
Likely dose
Nicotinamide 500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02213094
NCT02213094Phase 1Completed

Phase I Study of Nicotinamide for Early Onset Preeclampsia

University of North Carolina, Chapel Hill·interventional·Posted Aug 11, 2014·Updated Nov 2, 2018

In Brief

A Phase 1 clinical trial evaluating Nicotinamide 500 mg and Nicotinamide 1000 mg for Pregnancy Induced Hypertension and 2 related conditions. Completed, enrolled 10 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedAug 11, 2014
Enrollment StartJan 1, 2014
Primary CompletionDec 3, 2015
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 11.9 years ago

Interventions

Nicotinamide 500 mgdrug

Nicotinamide 500 mg taken by mouth each morning

Nicotinamide 1000 mgdrug

Nicotinamide 1000 mg taken by mouth each morning