Phase I Study of Nicotinamide for Early Onset Preeclampsia

Completed · Phase 1

Conditions studied: Pregnancy Induced Hypertension, Superimposed Preeclampsia, Hypertension

In brief

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.

Key facts

Study ID

NCT02213094

Run by

University of North Carolina, Chapel Hill

People needed

10

Starts

2014-01-01

Expected to finish

2015-12-03

Last updated by the study team

2018-11-02

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Maternal age 18-45 years
• Informed written consent
• Preeclampsia or new onset hypertension between 24-32 completed weeks' gestation
• 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;
• Dating criteria based on menstrual dating confirmed by first or second trimester ultrasound OR second trimester ultrasound if menstrual dating unavailable;
• Deemed clinically stable by primary clinician and candidate for expectant management (delayed delivery);
• Maternal liver function tests < 3x ULN
• Maternal platelet count > 100,000 mm3
• 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
• Plan for expectant management until delivery
• Delivery not anticipated within first 48 hours

You may not qualify if…

• Preeclampsia < 24 or > 33 weeks' gestation;
• Suspected fetal structural or chromosomal abnormality;
• Pre-existing renal disease (creatinine > 1.5 mg/dL)
• Pre-existing vascular disease (systemic lupus; cardiac disease;)
• Plan for delivery within 48 hours
• Any pre-existing medical condition that would increase risk for liver toxicity (e.g. hepatitis B or C; HIV)
• Evidence of cerebral dysfunction (seizures; cerebral edema on CT/MRI; headache unresolved with oral analgesics)
• Pulmonary edema
• HELLP (hemolysis, elevated liver enzymes, low platelets syndrome)
• Evidence of liver dysfunction (LFTs > 3x ULN)
• Thrombocytopenia (platelets < 100,000 mm3)
• Evidence of fetal compromise: EFW(estimated fetal weight) < 5th percentile; BPP < 6; absent or reverse diastolic UA blood flow; oligohydramnios (MVP < 2 cm)
• Placental abruption defined as unexplained vaginal bleeding
• Preterm labor defined as regular contractions and cervical change
• Any condition deemed by the investigator to be a risk to mother or fetus in completion of the study
• Any condition deemed by the investigator to require delivery within 48 hours

Where it is running

• University of North Carolina Women's Hospital — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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