Role of L-citrulline in Prevention of Pregnancy Associated Hypertension

Gestational Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04979793
• Other study ID #: 20-0167
• Status: Suspended
• Phase: Phase 1
• Start date: July 28, 2021
• Est. completion date: July 30, 2024

Study information

• Verified date: August 2023
• Source: The University of Texas Medical Branch, Galveston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 338
• Est. completion date: July 30, 2024
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Eclampsia
• Gestational Hypertension
• Hypertension
• Hypertension, Pregnancy-Induced
• Pre-Eclampsia
• Preeclampsia and Eclampsia
• Pregnancy Induced Hypertension

Intervention

Drug:
• L-citrulline
3 gram sachet, L-citrulline
• Placebo
Milk powder placebo

Locations

Country	Name	City	State
United States	University of Texas Medical Branch	Galveston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of pregnancy induced hypertension	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	To be assessed by chart review at time of delivery which generally will occur 8-9 months after randomization.
Secondary	Change in bioavailability of L-citrulline and asymmetric dimethyl arginine (ADMA) with oral L-citrulline administration	Assessment of change in serum L-citrulline and asymmetric dimethyl arginine (ADMA ) levels with L-citrulline administration between treatment and placebo groups. Serum samples will be collected at the beginning of study and after 8 weeks and assayed for ADMA and L-citrulline	Baseline at start of study and again after 8 weeks treatment
Secondary	Change in maternal nitric oxide levels with L-citrulline supplementation	Assessment of change in nitric oxide levels between treatment and placebo groups by measurement of baseline and 8 week post treatment urine nitrate and nitrite concentrations	Baseline at start of study and again after 8 weeks treatment
Secondary	Maternal blood pressure	Assessment of maternal blood pressure throughout study	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..
Secondary	Maternal Morbidity	Composite assessment of incidence of maternal outcomes to include development of preeclampsia; Hemolysis, Elevated liver enzymes, Low Platelets (HELLP) syndrome; eclampsia; indicated preterm birth less than 32 weeks due to hypertension related disorders	To be assessed by chart review at time of delivery which generally will occur 8-9 months after randomization.
Secondary	Birth weight	To assess the actual birthweight of neonate by chart review at time of delivery. This outcome is different than fetal growth restriction noted in outcome 5.	To be assessed by chart review at time of delivery which generally will occur 8-9 months after randomization.
Secondary	Neonatal Outcomes	To determine the incidence of neonatal outcomes by chart review after delivery that include respiratory distress syndrome, necrotising enterocolitis, bronchopulmonary dysplasia (BPD), and BPD related pulmonary hypertension, retinopathy of prematurity, age at full feed, and length of hospital stay, fetal growth restriction defined as less than 10% of predicted gestational age, fetal death after 20 weeks gestation, and neonatal death	To be assessed by chart review 8-9 months after enrollment at time of delivery