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

Nantes University Hospital (NUH)

Status and phase: Completed; Phase 3; Phase 2

Conditions: Pre-eclampsia; Pregnancy

Treatments: Drug: Placebo; Drug: Citrulline

Study type: Interventional

Funder types: Other

Identifiers

NCT02801695

RC15_0475

Details and patient eligibility

About

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.

Enrollment: 116 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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116 participants in 2 patient groups, including a placebo group

L-Citrulline

Experimental group

Description:

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

Treatment:

Drug: Citrulline

Lactose

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo