Evaluation of the Efficacy of Citrulline Supplementation on the Delay of Delivery for Women Hospitalized for Pre-eclampsia (CITRUPE)

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

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-20

Study Completion Date

2020-12-01

Brief Summary

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Pre-eclampsia (PE) complicates 2-8 % of pregnancies and is associated with high maternal and fetal morbidity and mortality. The early clinical manifestations are the occurrence of a maternal blood pressure and proteinuria. Placental dysfunction impairs the nutrient supply to the fetus, and may be the cause of an intrauterine growth retardation (IUGR). This is a disease that causes prematurity and currently the only known cure is delivery of the placenta. Nitrogen monoxide (NO) regulates the placental blood flow. However, pre-eclampsia is directly related to a failure of placental NO production. In this context, several clinical trials have tested the effect of NO donors such as L- arginine. However, supplementation with L -Arginine in a randomized trial in Nantes, has proved to be ineffective in severe vascular IUGR.

Citrulline is a natural aminoacid precursor to arginine and in contrast to L-arginine escapes uptake in the liver and appears directly in the peripheral blood converted by the kidney in arginine, released into the systemic circulation, Citrulline may therefore be more effective in the treatment of pre-eclampsia.

This prospective, randomized, comparative and double-blinded study aims to prolong pregnancy for patients with pre-eclampsia before 36 weeks.

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Detailed Description

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Conditions

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Pre-eclampsia Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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L-Citrulline

Bolus (9g) after patient stabilization, then 3g 3 times a day until delivery

Group Type EXPERIMENTAL

Citrulline

Intervention Type DRUG

Citrulline supplementation

Lactose

Bolus (9g) after patient stabilization, then 3g 3 times a day until delivery

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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Citrulline

Citrulline supplementation

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* age \>= 18 years old
* pregnant woman
* singleton pregnancy
* woman with pre-eclampsia (\<36 weeks) without indication of forthcoming extraction
* subjects affiliated with an appropriate social security system
* subjects out of context of guardianship
* written signed informed consent form

Exclusion Criteria

* age \< 18 years old
* isolated hypertension or isolated proteinuria
* severe pre-eclampsia with indication of forthcoming extraction in emergency
* term pregnancy \>= 36 Weeks when diagnosis is done
* multiple pregnancy
* lactose intolerance
* context of guardianship

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No