Role of L-citrulline in Prevention of Pregnancy Associated Hypertension

The University of Texas System (UT)

Status and phase: Suspended; Phase 1

Conditions: Preeclampsia and Eclampsia; Pregnancy Induced Hypertension; Gestational Hypertension

Treatments: Drug: Placebo; Drug: L-citrulline

Study type: Interventional

Funder types: Other

Identifiers

NCT04979793

20-0167

Details and patient eligibility

About

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.

Full 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.

Enrollment: 338 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

338 participants in 2 patient groups

Placebo

Active Comparator group

Description:

Oral placebo, 3 grams milk powder sachet, taken once daily

Treatment:

Drug: Placebo

Daily L-citrulline

Experimental group

Description:

L-citrulline, 3 grams L-citrulline sachet, taken once daily

Treatment:

Drug: L-citrulline