Role of L-citrulline in Prevention of Pregnancy Associated Hypertension in Nulliparous Women
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 入组人数
- 338
- 试验地点
- 1
- 主要终点
- Incidence of pregnancy induced hypertension
研究概览
简要总结
The target population for our study is healthy nulliparous pregnant women (first pregnancy) between the 12-16 week of pregnancy.
If a subject is eligible, written consent will be obtained by person to person contact. Eligible participants will be randomized to receive either daily L-citrulline supplementation or placebo.
详细描述
Healthy nulliparous pregnant women (first pregnancy) between the 12-16 week of pregnancy will be eligible for this study. The purpose of this study will be to determine if daily supplementation of oral L-citrulline can reduce the incidence of pregnancy induced hypertension. This will be a double blind study, subjects will be randomized to receive either L-citrulline (3 gram sachet) or a placebo for a total of 8 weeks. Participants will be asked to provide urine and blood samples at time of enrollment, be asked to respond to a phone survey to assess for side effects, and again be asked to provide urine and blood samples at the end of 8 weeks. Participants will continue with routine prenatal care throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Nulliparous (no previous pregnancy greater than 20 weeks)
- •Gestational age of pregnancy between 12 and 16 weeks
排除标准
- •Known fetal anomaly or chromosomal abnormality
- •Early fetal growth restriction
- •Fetal demise or planned termination
- •Participation in another study that may influence this study
- •Known maternal kidney disease
- •Known maternal electrolyte imbalance
- •Known allergies to study interventions
- •Preexisting hypertension (chronic hypertension)
- •Known gastric ulcer
- •Incarcerated status
- •Planned delivery at non-UTMB hospital
- •Known lactose intolerance
研究组 & 干预措施
Placebo
Oral placebo, 3 grams milk powder sachet, taken once daily
干预措施: Placebo (Drug)
Daily L-citrulline
L-citrulline, 3 grams L-citrulline sachet, taken once daily
干预措施: L-citrulline (Drug)
结局指标
主要结局
Incidence of pregnancy induced hypertension
时间窗: To be assessed by chart review at time of delivery which generally will occur 8-9 months after randomization.
Incidence of pregnancy induced hypertension conditions (gestational hypertension, preeclampsia, or eclampsia) between treatment and placebo groups will be assessed by chart review after end of pregnancy
次要结局
- Change in bioavailability of L-citrulline and asymmetric dimethyl arginine (ADMA) with oral L-citrulline administration(Baseline at start of study and again after 8 weeks treatment)
- Change in maternal nitric oxide levels with L-citrulline supplementation(Baseline at start of study and again after 8 weeks treatment)
- Maternal blood pressure(Baseline at start of study, and approximately every 1-4 weeks after randomization at prenatal appointments throughout pregnancy. Also at time of delivery approximately 8-9 months after randomization..)
- Maternal Morbidity(To be assessed by chart review at time of delivery which generally will occur 8-9 months after randomization.)
- Birth weight(To be assessed by chart review at time of delivery which generally will occur 8-9 months after randomization.)
- Neonatal Outcomes(To be assessed by chart review 8-9 months after enrollment at time of delivery)