- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02363348
Efficacy and Safety of L Arginine to Prevent Preeclampsia
Efficacy and Safety of L Arginine to Prevent Preeclampsia in High Risk Pregnancies
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
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Jalisco
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Guadalajara, Jalisco, Mexico, 44340
- Panduro Baron J Guadalupe
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo (A)
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. |
calcined magnesia
|
Experimental: L arginine (B)
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.
|
L arginine is a basic amino-acid precursor of nitric oxide main vasodilator.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
efficacy of L arginine to prevent preeclampsia
Time Frame: from time of randomization until the date of diagnostic of preeclampsia or two weeks after delivery wichever came first. approximalety 20 weeks.
|
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
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from time of randomization until the date of diagnostic of preeclampsia or two weeks after delivery wichever came first. approximalety 20 weeks.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
perinatal outcome
Time Frame: from time to delivery until two weeks after, approximalety 18 weeks
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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
|
from time to delivery until two weeks after, approximalety 18 weeks
|
safety of L arginine
Time Frame: from time of randomization until birth approximalety 18 weeks
|
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)
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from time of randomization until birth approximalety 18 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Guadalupe Panduro, Ph, Hospital Civil Juan I. Menchaca
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SSJ1054-11
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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