Phase I Study of Nicotinamide for Early Onset Preeclampsia
| Status: | Completed |
|---|---|
| Conditions: | High Blood Pressure (Hypertension), Women's Studies |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Reproductive |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 11/4/2018 |
| Start Date: | January 1, 2014 |
| End Date: | December 3, 2015 |
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.
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.
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
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