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 range18 Years

SexFEMALE

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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

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