Phase I Study of Nicotinamide for Early Onset Preeclampsia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Events
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Nicotinamide 500 mg
Nicotinamide 500 mg by mouth each morning until delivery or 14 days, whichever occurs first.
干预措施: Nicotinamide 500 mg (Drug)
Nicotinamide 1000 mg
Nicotinamide 1000 mg by mouth each morning until delivery or 14 days, whichever occurs first.
干预措施: Nicotinamide 1000 mg (Drug)
结局指标
主要结局
Number of Participants With Adverse Events
时间窗: Within 48 hours of dosing
Specific adverse events were Maternal liver toxicity, defined as \> 3x ULN of ALT(Alanine amniotransferase) or AST (Aspartate amniotransferase), maternal report of side effects, and fetal adverse effects.
次要结局
未报告次要终点