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Amino Acid

L-citrulline for Pre-eclampsia

Phase 1

Waitlist Available

Research Sponsored by The University of Texas Medical Branch, Galveston

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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..

Awards & highlights

Study Summary

This trial is testing whether L-citrulline supplementation is safe and improves blood flow in healthy nulliparous pregnant women.

Eligible Conditions

Pre-eclampsia
Hypertension
Preeclampsia and Eclampsia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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..

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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..

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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.. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of pregnancy induced hypertension

Secondary outcome measures

Birth weight

Change in bioavailability of L-citrulline and asymmetric dimethyl arginine (ADMA) with oral L-citrulline administration

Change in maternal nitric oxide levels with L-citrulline supplementation

+3 more

Side effects data

From 2019 Phase 3 trial • 189 Patients • NCT02891837

19%

Pyrexia

16%

Pain

14%

Restlessness

12%

Hypokalaemia

12%

Tachycardia

12%

Pleural effusion

12%

Hypertension

11%

Constipation

Atelectasis

Haemoglobin decreased

Hypocalcaemia

Hypotension

Oligurea

Vomiting

Electrolyte imbalance

Stridor

Pulmonary oedema

Chylothorax

Tachypnoea

Coagulation time prolonged

C-reactive protein increased

Metabolic acidosis

Pulmonary congestion

Anaemia

Cough

Diarrhoea

Sinus bradycardia

Blood creatine phosphokinase increased

Blood lactate dehydrogenase increased

Leukopenia

Atrioventricular block complete

Cardiac output decreased

Thrombocytopenia

Oedema peripheral

Arrhythmia

Cardiac failure

Adrenal insufficiency

Hypoalbuminaemia

Aortic valve incompetence

Post procedural haemorrhage

Haematocrit decreased

Aspartate aminotransferase increased

Staphylococcal infection

Nausea

Cardiac tamponade

Ventricular fibrillation

Blood lactic acid increased

Ventricular tachycardia

Junctional ectopic tachycardia

Swallow study abnormal

Coagulopathy

Leukocytosis

Atrioventricular block

Supraventricular extrasystoles

Hypothermia

Oedema

Peripheral swelling

Secretion discharge

Respiratory arrest

Hypomagnesaemia

Respiratory failure

100%

80%

60%

40%

20%

Study treatment Arm

L-citrulline - All Patients

L-citrulline - All Patients on Mechanical Ventilation for ≤48 Hours

L-citrulline - US Patients on Mechanical Ventilation for >48 Hours

Placebo - All Patients

L-citrulline - US Patients on Mechanical Ventilation for ≤48 Hours

L-citrulline - All Patients on Mechanical Ventilation for >48 Hours

Placebo - All Patients on Mechanical Ventilation for ≤48 Hours

Placebo - US Patients on Mechanical Ventilation for ≤48 Hours

Placebo - All Patients on Mechanical Ventilation for >48 Hours

Placebo - US Patients on Mechanical Ventilation for >48 Hours

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Daily L-citrullineExperimental Treatment1 Intervention

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

Group II: PlaceboActive Control1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Citrulline

Not yet FDA approved

Do I qualify?Apply below to find out

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

The University of Texas Medical Branch, GalvestonLead Sponsor

241 Previous Clinical Trials

56,260 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are actively engaged in this medical experiment?

"Affirmative. Clinicaltrials.gov lists the trial as actively recruiting participants since it was first posted on July 28th 2021, with most recent changes made on August 2nd 2021. This medical study calls for 338 patients to be enrolled at a single site."

Answered by AI

Can you tell me what exploratory investigations have been done with L-citrulline?

"Currently, there are 4 clinical trials for L-citrulline in circulation with none of them having reached Phase 3. The majority of the experiments based on this molecule occur in Durham, North carolina. There are also other locations conducting research into its effects as well."

Answered by AI

What potential risks should be taken into consideration when prescribing L-citrulline?

"As this is a Phase 1 trial, there isn't much data to support the safety or efficacy of L-citrulline. Our team at Power estimates that it should be given a score of 1 on our scale."

Answered by AI

Is this experiment in need of any additional participants at present?

"Affirmative. Clinicaltrials.gov states that this clinical trial is currently seeking out participants, with the initial post on July 28th 2021 and its most recent update occurring in August 2nd 2021. 338 individuals must be recruited from one particular site for the experiment to properly begin."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Role of L-citrulline in Prevention of Pregnancy Associated Hypertension

2021. "Role of L-citrulline in Prevention of Pregnancy Associated Hypertension". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04979793.