Clinical trial NCT04979793: Role of L-citrulline in Prevention of Pregnancy Associated Hypertension
Official title: Role of L-citrulline in Prevention of Pregnancy Associated Hypertension in Nulliparous Women
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE1
Conditions: Pregnancy Induced Hypertension
Preeclampsia and Eclampsia
Gestational Hypertension
Keywords: Pregnancy Induced Hypertension
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
First posted: 2021-07-28
Enrollment: 338
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Nulliparous (no previous pregnancy greater than 20 weeks)
* Gestational age of pregnancy between 12 and 16 weeks

Exclusion Criteria:

* 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

Primary outcomes:
measure: Incidence of pregnancy induced hypertension
timeFrame: To be assessed by chart review at time of delivery which generally will occur 8-9 months after randomization.
Secondary outcomes:
measure: Change in bioavailability of L-citrulline and asymmetric dimethyl arginine (ADMA) with oral L-citrulline administration
timeFrame: Baseline at start of study and again after 8 weeks treatment
measure: Change in maternal nitric oxide levels with L-citrulline supplementation
timeFrame: Baseline at start of study and again after 8 weeks treatment
measure: Maternal blood pressure
timeFrame: 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..
measure: Maternal Morbidity
timeFrame: To be assessed by chart review at time of delivery which generally will occur 8-9 months after randomization.
measure: Birth weight
timeFrame: To be assessed by chart review at time of delivery which generally will occur 8-9 months after randomization.
measure: Neonatal Outcomes
timeFrame: To be assessed by chart review 8-9 months after enrollment at time of delivery
Other outcomes:
Locations:
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
Study officials:
References: