Phase 1
N=10
Phase I Study of Nicotinamide for Early Onset Preeclampsia
Pregnancy Induced Hypertension · Superimposed Preeclampsia · Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT02213094 ↗Enrolled (actual)
10
Serious AEs
20.0%
Results posted
Nov 2018
Primary outcome: Primary: Number of Participants With Adverse Events — 2; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Nicotinamide 500 mg (Drug); Nicotinamide 1000 mg (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
2; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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 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
Exclusion Criteria
- Preeclampsia 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
Data sourced from ClinicalTrials.gov (NCT02213094). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.