NCT02213094

Phase I Study of Nicotinamide for Early Onset Preeclampsia

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pregnancy Induced Hypertension
• Superimposed Preeclampsia
• Hypertension

Interventions

Type	Name	Description
DRUG	Nicotinamide 500 mg	Nicotinamide 500 mg taken by mouth each morning
DRUG	Nicotinamide 1000 mg	Nicotinamide 1000 mg taken by mouth each morning

Timeline

• Start date: 2014-01-01
• Primary completion: 2015-12-03
• Completion: 2015-12-03
• First posted: 2014-08-11
• Last updated: 2018-11-02
• Results posted: 2018-11-02

Locations

1 site across 1 country: United States