NCT04979793

Role of L-citrulline in Prevention of Pregnancy Associated Hypertension

Role of L-citrulline in Prevention of Pregnancy Associated Hypertension in Nulliparous Women

• Status: Suspended
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 338 (estimated)
• Sponsor: The University of Texas Medical Branch, Galveston · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pregnancy Induced Hypertension
• Preeclampsia and Eclampsia
• Gestational Hypertension

Interventions

Type	Name	Description
DRUG	L-citrulline	3 gram sachet, L-citrulline
DRUG	Placebo	Milk powder placebo

Timeline

• Start date: 2021-07-28
• Primary completion: 2027-07-30
• Completion: 2027-07-30
• First posted: 2021-07-28
• Last updated: 2025-09-19

Locations

1 site across 1 country: United States