Back to resultsEvaluation of the Efficacy of Citrulline Supplementation on the Delay of Delivery for Women Hospitalized for Pre-eclampsia (CITRUPE) (CITRUPE)
Primary Purpose
Pre-eclampsia, Pregnancy
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Citrulline
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pre-eclampsia focused on measuring pre-eclampsia, citrulline, pregnancy
Eligibility 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
Sites / Locations
- CHU de Nantes
- Hôpital Cochin (Maternité Port-Royal)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
L-Citrulline
Lactose
Arm Description
Bolus (9g) after patient stabilization, then 3g 3 times a day until delivery
Bolus (9g) after patient stabilization, then 3g 3 times a day until delivery
Outcomes
Primary Outcome Measures
number of days between the therapeutic initiation and childbirth
Secondary Outcome Measures
Full Information
NCT ID
NCT02801695
First Posted
June 3, 2016
Last Updated
January 21, 2021
Sponsor
Nantes University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02801695
Brief Title
Evaluation of the Efficacy of Citrulline Supplementation on the Delay of Delivery for Women Hospitalized for Pre-eclampsia (CITRUPE)
Acronym
CITRUPE
Official Title
Evaluation of the Efficacy of Citrulline Supplementation on the Delay of Delivery for Women Hospitalized for Pre-eclampsia (CITRUPE)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
February 20, 2017 (Actual)
Primary Completion Date
December 1, 2020 (Actual)
Study Completion Date
December 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-eclampsia, Pregnancy
Keywords
pre-eclampsia, citrulline, pregnancy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
116 (Actual)
8. Arms, Groups, and Interventions
Arm Title
L-Citrulline
Arm Type
Experimental
Arm Description
Bolus (9g) after patient stabilization, then 3g 3 times a day until delivery
Arm Title
Lactose
Arm Type
Placebo Comparator
Arm Description
Bolus (9g) after patient stabilization, then 3g 3 times a day until delivery
Intervention Type
Drug
Intervention Name(s)
Citrulline
Intervention Description
Citrulline supplementation
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
number of days between the therapeutic initiation and childbirth
Time Frame
childbirth
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nobert Winer, Dr
Organizational Affiliation
Nantes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Hôpital Cochin (Maternité Port-Royal)
City
Paris
ZIP/Postal Code
75014
Country
France
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Efficacy of Citrulline Supplementation on the Delay of Delivery for Women Hospitalized for Pre-eclampsia (CITRUPE)
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