Back to resultsEfficacy and Safety of L Arginine to Prevent Preeclampsia
Primary Purpose
Preeclampsia
Status
Completed
Phase
Phase 3
Locations
Mexico
Study Type
Interventional
Intervention
L arginine
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Preeclampsia focused on measuring L arginine, Preeclampsia
Eligibility Criteria
Inclusion Criteria:
- one or more risk factors for developing preeclampsia (nulliparous, previous history of preeclampsia, chronic hypertension, BMI ≥30)
Exclusion Criteria:
- pregnant women carriers of chronic renal failure
- pre gestational diabetes
- multiple pregnancy and were removed for some reason they received medication that would interfere with the interpretation of results (aspirin)
Sites / Locations
- Panduro Baron J Guadalupe
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo (A)
L arginine (B)
Arm Description
were administered 5 capsules per day each capsule contained 600 mg of magnesia calcinada. Duration: from week 20th of pregnancy until the end of the same. dose was administered as follows: two capsules in the morning at breakfast and three capsules at night in dinner.
were administered 5 capsules per day each capsule contained 600 mg of L arginine. Duration: from week 20th of pregnancy until the end of the same dose was administered as follows: two capsules in the morning at breakfast and three capsules at night in dinner.
Outcomes
Primary Outcome Measures
efficacy of L arginine to prevent preeclampsia
number of patients with diagnosis of preeclampsia. the diagnostic was performed when they presented arterial blood pressure above 140/90 mm / Hg in the span of 6 hours and accompanied by proteinuria (>300 milligrams in one sample) number of patients with high blood pression and proteinuria (ACOG criteria) The evaluations were performed every three weeks until week 31, then every two weeks until week 35 and weekly until pregnancy ended
Secondary Outcome Measures
perinatal outcome
number of patients with adverse perinatal outcome: APGAR scale < 7 at five minutes, low weight for gestational age (< 10 percentile) and CAPURRO scale < 37 weeks also the need to enter the neonatal intensive care unit
safety of L arginine
number of patients with adverse reactions and/or any alteration of blood test. participants are awarded a diary which recorded the symptoms that caused them any discomfort. If the discomfort was important it was reported via telephone with the treating physician. the paper was reviewed at each appointment. Blood tests such as blood count, liver function tests and kidney were performed every three weeks in search of alterations in the parameters considered normal by those tests (ACOG criteria)
Full Information
NCT ID
NCT02363348
First Posted
January 27, 2015
Last Updated
March 3, 2016
Sponsor
Hospital Civil Juan I. Menchaca
1. Study Identification
Unique Protocol Identification Number
NCT02363348
Brief Title
Efficacy and Safety of L Arginine to Prevent Preeclampsia
Official Title
Efficacy and Safety of L Arginine to Prevent Preeclampsia in High Risk Pregnancies
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Civil Juan I. Menchaca
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Randomized double-blind controled clinical trial to assess the efficacy and safety of L-arginine to prevent preeclampsia.
applied to pregnant women with risk factors for preeclampsia. the main result was the development of preeclampsia as well as side effects to taking l arginine besides perinatal outcomes
Detailed Description
Two groups were formed. one received L arginine 3 grams orally at day from the 20th week of pregnancy. the other group received placebo.
Each three weeks were evaluated in search of high blood pressure and proteinuria.
The follow-up was until the end of pregnancy and two weeks after this
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preeclampsia
Keywords
L arginine, Preeclampsia
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
96 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo (A)
Arm Type
Placebo Comparator
Arm Description
were administered 5 capsules per day each capsule contained 600 mg of magnesia calcinada. Duration: from week 20th of pregnancy until the end of the same.
dose was administered as follows: two capsules in the morning at breakfast and three capsules at night in dinner.
Arm Title
L arginine (B)
Arm Type
Experimental
Arm Description
were administered 5 capsules per day each capsule contained 600 mg of L arginine. Duration: from week 20th of pregnancy until the end of the same dose was administered as follows: two capsules in the morning at breakfast and three capsules at night in dinner.
Intervention Type
Dietary Supplement
Intervention Name(s)
L arginine
Intervention Description
L arginine is a basic amino-acid precursor of nitric oxide main vasodilator.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
calcined magnesia
Primary Outcome Measure Information:
Title
efficacy of L arginine to prevent preeclampsia
Description
number of patients with diagnosis of preeclampsia. the diagnostic was performed when they presented arterial blood pressure above 140/90 mm / Hg in the span of 6 hours and accompanied by proteinuria (>300 milligrams in one sample) number of patients with high blood pression and proteinuria (ACOG criteria) The evaluations were performed every three weeks until week 31, then every two weeks until week 35 and weekly until pregnancy ended
Time Frame
from time of randomization until the date of diagnostic of preeclampsia or two weeks after delivery wichever came first. approximalety 20 weeks.
Secondary Outcome Measure Information:
Title
perinatal outcome
Description
number of patients with adverse perinatal outcome: APGAR scale < 7 at five minutes, low weight for gestational age (< 10 percentile) and CAPURRO scale < 37 weeks also the need to enter the neonatal intensive care unit
Time Frame
from time to delivery until two weeks after, approximalety 18 weeks
Title
safety of L arginine
Description
number of patients with adverse reactions and/or any alteration of blood test. participants are awarded a diary which recorded the symptoms that caused them any discomfort. If the discomfort was important it was reported via telephone with the treating physician. the paper was reviewed at each appointment. Blood tests such as blood count, liver function tests and kidney were performed every three weeks in search of alterations in the parameters considered normal by those tests (ACOG criteria)
Time Frame
from time of randomization until birth approximalety 18 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
one or more risk factors for developing preeclampsia (nulliparous, previous history of preeclampsia, chronic hypertension, BMI ≥30)
Exclusion Criteria:
pregnant women carriers of chronic renal failure
pre gestational diabetes
multiple pregnancy and were removed for some reason they received medication that would interfere with the interpretation of results (aspirin)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guadalupe Panduro, Ph
Organizational Affiliation
Hospital Civil Juan I. Menchaca
Official's Role
Study Chair
Facility Information:
Facility Name
Panduro Baron J Guadalupe
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44340
Country
Mexico
12. IPD Sharing Statement
Citations:
PubMed Identifier
24313856
Citation
Johal T, Lees CC, Everett TR, Wilkinson IB. The nitric oxide pathway and possible therapeutic options in pre-eclampsia. Br J Clin Pharmacol. 2014 Aug;78(2):244-57. doi: 10.1111/bcp.12301.
Results Reference
background
PubMed Identifier
21596735
Citation
Vadillo-Ortega F, Perichart-Perera O, Espino S, Avila-Vergara MA, Ibarra I, Ahued R, Godines M, Parry S, Macones G, Strauss JF. Effect of supplementation during pregnancy with L-arginine and antioxidant vitamins in medical food on pre-eclampsia in high risk population: randomised controlled trial. BMJ. 2011 May 19;342:d2901. doi: 10.1136/bmj.d2901.
Results Reference
result
Learn more about this trial
Efficacy and Safety of L Arginine to Prevent Preeclampsia
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