Pregnancy Induced HypertensionPhase 1NCT04979793
Role of L-citrulline in Prevention of Pregnancy Associated Hypertension
A Phase 1 study testing L-citrulline in people with Pregnancy Induced Hypertension and Preeclampsia and Eclampsia, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Induced Hypertension, Preeclampsia and Eclampsia, Gestational Hypertension
- What is being tested?
- L-citrulline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jul 2021to 12 Dec 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Nulliparous (no previous pregnancy greater than 20 weeks)
- Gestational age of pregnancy between 12 and 16 weeks
Who cannot join
- 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
Show all 12Show fewer
- Known allergies to study interventions
- Preexisting hypertension (chronic hypertension)
- Known gastric ulcer
- Incarcerated status
- Planned delivery at non-UTMB hospital
- Known lactose intolerance
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Medical Branch
Galveston, Texas, 77555-0156
About this study
Official title: Role of L-citrulline in Prevention of Pregnancy Associated Hypertension in Nulliparous Women
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.
Read the detailed 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.
- Being tested
- L-citrulline, Placebo
- Keywords
- Pregnancy Induced Hypertension
- Medical subject headings
- Hypertension, Pregnancy-Induced, Pre-Eclampsia, Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-citrullineDrug
3 gram sachet, L-citrulline
PlaceboDrug
Milk powder placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Active comparator | Oral placebo, 3 grams milk powder sachet, taken once daily Receives: Drug: Placebo |
| Daily L-citrulline | Experimental | L-citrulline, 3 grams L-citrulline sachet, taken once daily Receives: Drug: L-citrulline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: Baseline at start of study and again after 8 weeks treatment
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
Measured: Baseline at start of study and again after 8 weeks treatment
Maternal blood pressure
Assessment of maternal blood pressure throughout study
Measured: 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
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
Measured: To be assessed by chart review at time of delivery which generally will occur 8-9 months after randomization.
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.
Measured: To be assessed by chart review at time of delivery which generally will occur 8-9 months after randomization.
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
Measured: To be assessed by chart review 8-9 months after enrollment at time of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start28 Jul 2021
- Primary completion12 Dec 2025
- Study completion12 Dec 2025
Why it stopped: At the request of the PI
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy Induced HypertensionStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04979793
- Sponsor's protocol ID
- 20-0167
- Status last verified
- Sep 2025
- First submitted
- 16 Jun 2021
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of L-citrulline in Prevention of Pregnancy Associated Hypertension in Nulliparous Women
- ClinicalTrials.gov ID
- NCT04979793
- Acronym / sponsor ID
- 20-0167
- Keywords
- Pregnancy Induced Hypertension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: At the request of the PI
- Enrolment
- 3 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- 28 Jul 2021 (actual)
- Primary completion
- 12 Dec 2025 (actual)
- Study completion
- 12 Dec 2025 (actual)
- First posted
- 28 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Active comparator | Drug: PlaceboOral placebo, 3 grams milk powder sachet, taken once daily |
| Daily L-citrulline | Experimental | Drug: L-citrullineL-citrulline, 3 grams L-citrulline sachet, taken once daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Nulliparous (no previous pregnancy greater than 20 weeks)
- Gestational age of pregnancy between 12 and 16 weeks
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L-citrulline3 gram sachet, L-citrulline | Drug | Daily L-citrulline |
| PlaceboMilk powder placebo | Drug | Placebo |
Primary outcome
Incidence of pregnancy induced hypertension
Time frame: To be assessed by chart review at time of delivery which generally will occur 8-9 months after randomization.
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
6 secondary outcomes
Change in bioavailability of L-citrulline and asymmetric dimethyl arginine (ADMA) with oral L-citrulline administration
Time frame: Baseline at start of study and again after 8 weeks treatment
Change in maternal nitric oxide levels with L-citrulline supplementation
Time frame: Baseline at start of study and again after 8 weeks treatment
Maternal blood pressure
Time frame: 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
Time frame: To be assessed by chart review at time of delivery which generally will occur 8-9 months after randomization.
Birth weight
Time frame: To be assessed by chart review at time of delivery which generally will occur 8-9 months after randomization.
Neonatal Outcomes
Time frame: To be assessed by chart review 8-9 months after enrollment at time of delivery
Results and safety
The study was stopped early (reason given: At the request of the PI). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing L-citrulline in people with Pregnancy Induced Hypertension and Preeclampsia and Eclampsia, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: At the request of the PI). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of pregnancy induced hypertension (time frame: To be assessed by chart review at time of delivery which generally will occur 8-9 months after randomization.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.