Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02801695
Recruitment Status : Recruiting
First Posted : June 16, 2016
Last Update Posted : December 19, 2018
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Pre-eclampsia Pregnancy Drug: Citrulline Drug: Placebo Phase 2 Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy of Citrulline Supplementation on the Delay of Delivery for Women Hospitalized for Pre-eclampsia (CITRUPE)
Actual Study Start Date : February 20, 2017
Estimated Primary Completion Date : October 20, 2020
Estimated Study Completion Date : October 20, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: L-Citrulline
Bolus (9g) after patient stabilization, then 3g 3 times a day until delivery
Drug: Citrulline
Citrulline supplementation

Placebo Comparator: Lactose
Bolus (9g) after patient stabilization, then 3g 3 times a day until delivery
Drug: Placebo
Placebo




Primary Outcome Measures :
  1. number of days between the therapeutic initiation and childbirth [ Time Frame: childbirth ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02801695


Contacts
Layout table for location contacts
Contact: Norbert Winer, Dr +332 40 08 31 90 nobert.winer@chu-nantes.fr
Contact: Guillaume Ducarme, Dr +332 51 44 65 70 guillaume.ducarme@chd-vendee.fr

Locations
Layout table for location information
France
CHD Vendée Recruiting
La Roche sur Yon, France, 85925
Contact: Guillaume Ducarme, Dr       guillaume.ducarme@chd-vendee.fr   
Principal Investigator: Guillaume Ducarme, Dr         
CHU de Nantes Recruiting
Nantes, France, 44093
Contact: Norbert Winer, Dr       nobert.winer@chu-nantes.fr   
Principal Investigator: Norbert Winer, Dr         
Sponsors and Collaborators
Nantes University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Nobert Winer, Dr CHU de Nantes

Layout table for additonal information
Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT02801695     History of Changes
Other Study ID Numbers: RC15_0475
First Posted: June 16, 2016    Key Record Dates
Last Update Posted: December 19, 2018
Last Verified: December 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nantes University Hospital:
pre-eclampsia
citrulline
pregnancy

Additional relevant MeSH terms:
Layout table for MeSH terms
Eclampsia
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications