Efficacy and Safety of L Arginine to Prevent Preeclampsia

• ClinicalTrials.gov Identifier: NCT02363348
• Recruitment Status: Completed
• First Posted: February 16, 2015
• Last Update Posted: March 4, 2016
• Sponsor: Hospital Civil Juan I. Menchaca
• Information provided by (Responsible Party): Eva Elizabet Camarena Pulido, Hospital Civil Juan I. Menchaca

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

Condition or disease	Intervention/treatment	Phase
Preeclampsia	Dietary Supplement: L arginine; Other: Placebo	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 96 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Prevention
• Official Title: Efficacy and Safety of L Arginine to Prevent Preeclampsia in High Risk Pregnancies
• Study Start Date: August 2010
• Actual Primary Completion Date: August 2013
• Actual Study Completion Date: March 2014

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. perinatal outcome [ Time Frame: from time to delivery until two weeks after, approximalety 18 weeks ]
   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
2. 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)

Eligibility Criteria

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

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)

Contacts and Locations

Locations

Mexico

Panduro Baron J Guadalupe

Guadalajara, Jalisco, Mexico, 44340

Sponsors and Collaborators

Hospital Civil Juan I. Menchaca

Investigators

• Study Chair: Guadalupe Panduro, Ph; Hospital Civil Juan I. Menchaca

More Information

Publications of Results:

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.

Other 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.

• Responsible Party: Eva Elizabet Camarena Pulido, MD, Hospital Civil Juan I. Menchaca
• ClinicalTrials.gov Identifier: NCT02363348
• Other Study ID Numbers: SSJ1054-11
• First Posted: February 16, 2015
• Last Update Posted: March 4, 2016
• Last Verified: March 2016

Keywords provided by Eva Elizabet Camarena Pulido, Hospital Civil Juan I. Menchaca:

L arginine; Preeclampsia

Additional relevant MeSH terms:

Pre-Eclampsia; Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases