Phase I Study of Nicotinamide for Early Onset Preeclampsia
Status:
Completed
Trial end date:
2015-12-03
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborator:
North Carolina Translational and Clinical Sciences Institute
Treatments:
Niacin Niacinamide Nicotinic Acids Vitamin B Complex Vitamins