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NCT Number: NCT02801695

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

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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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

CHU de Nantes, Nantes, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Citrulline

Drug

Citrulline supplementation

Placebo

Drug

Placebo

Primary outcomes

  1. number of days between the therapeutic initiation and childbirth

    Time frame: childbirth

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Acronym: CITRUPE

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jun 16, 2016
Registry last updated
Jan 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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