Phase I Study of Nicotinamide for Early Onset Preeclampsia

University of North Carolina, Chapel Hill10 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Pregnancy Induced Hypertension Superimposed Preeclampsia Hypertension

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Maternal age 18-45 years 2. Informed written consent 3. Preeclampsia or new onset hypertension between 24-32 completed weeks' gestation 1. Hypertensive complications of pregnancy defined as new onset systolic BP \> 140 mm Hg and/or diastolic BP \> 90 mm Hg on two occasions 6 hours apart; OR \> 300 mg proteinuria on 24 hour urine collection OR urine P/C ratio \>0.3; 2. Dating criteria based on menstrual dating confirmed by first or second trimester ultrasound OR second trimester ultrasound if menstrual dating unavailable; 3. Deemed clinically stable by primary clinician and candidate for expectant management (delayed delivery); 4. Maternal liver function tests \< 3x ULN 5. Maternal platelet count \> 100,000 mm3 6. Fetal well-being established by estimated fetal weight \> 5th %tile; normal amniotic fluid volume (MVP \> 2 cm); normal Umbilical Artery Dopplers; AND reactive NST(non-stress test) or BPP (biophysical profile) \> 6 7. Plan for expectant management until delivery 8. Delivery not anticipated within first 48 hours Exclusion Criteria: 1. Preeclampsia \< 24 or \> 33 weeks' gestation; 2. Suspected fetal structural or chromosomal abnormality; 3. Pre-existing renal disease (creatinine \> 1.5 mg/dL) 4. Pre-existing vascular disease (systemic lupus; cardiac disease;) 5. Plan for delivery within 48 hours 6. Any pre-existing medical condition that would increase risk for liver toxicity (e.g. hepatitis B or C; HIV) 7. Evidence of cerebral dysfunction (seizures; cerebral edema on CT/MRI; headache unresolved with oral analgesics) 8. Pulmonary edema 9. HELLP (hemolysis, elevated liver enzymes, low platelets syndrome) 10. Evidence of liver dysfunction (LFTs \> 3x ULN) 11. Thrombocytopenia (platelets \< 100,000 mm3) 12. Evidence of fetal compromise: EFW(estimated fetal weight) \< 5th percentile; BPP \< 6; absent or reverse diastolic UA blood flow; oligohydramnios (MVP \< 2 cm) 13. Placental abruption defined as unexplained vaginal bleeding 14. Preterm labor defined as regular contractions and cervical change 15. Any condition deemed by the investigator to be a risk to mother or fetus in completion of the study 16. Any condition deemed by the investigator to require delivery within 48 hours

Phase I Study of Nicotinamide for Early Onset Preeclampsia

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes