Role of L-citrulline in Prevention of Pregnancy Associated Hypertension

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

PHASE1

Total Enrollment

338 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-28

Study Completion Date

2027-07-30

Brief Summary

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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.

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Detailed Description

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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

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Pregnancy Induced Hypertension Preeclampsia and Eclampsia Gestational Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo

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

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type DRUG

Milk powder placebo

Daily L-citrulline

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

Group Type EXPERIMENTAL

L-citrulline

Intervention Type DRUG

3 gram sachet, L-citrulline

Interventions

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L-citrulline

3 gram sachet, L-citrulline

Intervention Type DRUG

Placebo

Milk powder placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes