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: Completed
• Conditions: Preeclampsia
• Intervention / Treatment: Other: Placebo; Dietary supplement: L arginine

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: Interventional
• Enrollment (Actual): 96
• Phase: Phase 3

Contacts and Locations

Study Locations

• Mexico
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44340
      • Panduro Baron J Guadalupe

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

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

Number of Arms

2

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.	Other: Placebo; 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.	Dietary supplement: L arginine; 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	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	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	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	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)	from time of randomization until birth approximalety 18 weeks

Collaborators and Investigators

• Sponsor: Hospital Civil Juan I. Menchaca
• 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: August 1, 2010
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: January 27, 2015
• First Submitted That Met QC Criteria: February 9, 2015
• First Posted (Estimate): February 16, 2015

Study Record Updates

• Last Update Posted (Estimate): March 4, 2016
• Last Update Submitted That Met QC Criteria: March 3, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Preeclampsia; L arginine
• Additional Relevant MeSH Terms: Pregnancy Complications; Hypertension, Pregnancy-Induced; Pre-Eclampsia
• Other Study ID Numbers: SSJ1054-11