At a glance
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Phase I Study of Nicotinamide for Early Onset Preeclampsia
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
Timeline
Interventions
Nicotinamide 500 mg taken by mouth each morning
Nicotinamide 1000 mg taken by mouth each morning