SuspendedPhase 1

Role of L-citrulline in Prevention of Pregnancy Associated Hypertension

Stopped: At the request of the PI

United States338 participantsStarted 2021-07-28

Plain-language 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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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.

Trial details

NCT IDNCT04979793

SponsorThe University of Texas Medical Branch, Galveston

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-07-30

View on ClinicalTrials.gov More Pregnancy Induced Hypertension trials