Role of L-citrulline in Prevention of Pregnancy Associated Hypertension

NCT04979793 | Suspended Phase 1 DMC

• 1 other identifier: 20-0167
• Study Type: interventional
• Target: 338
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Induced Hypertension; Preeclampsia and Eclampsia; Gestational Hypertension

Keywords

Pregnancy Induced Hypertension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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.

Study Arms (2)

Placebo

ACTIVE COMPARATOR

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

Drug: Placebo

Daily L-citrulline

EXPERIMENTAL

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

Drug: L-citrulline

Interventions

L-citrulline DRUG

3 gram sachet, L-citrulline

Daily L-citrulline

Placebo DRUG

Milk powder placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

University of Texas Medical Branch

Galveston, Texas, 77555-0156, United States

Location

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced; Pre-Eclampsia; Eclampsia

Interventions

Citrulline

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Diamino; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2021
• First Posted: July 28, 2021
• Study Start: July 28, 2021
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): July 30, 2027
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)