Efficacy and Safety of L Arginine to Prevent Preeclampsia

Preeclampsia Clinical Trial

Official title:

Efficacy and Safety of L Arginine to Prevent Preeclampsia in High Risk Pregnancies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02363348
• Other study ID #: SSJ1054-11
• Status: Completed
• Phase: Phase 3
• First received: January 27, 2015
• Last updated: March 3, 2016
• Start date: August 2010
• Est. completion date: March 2014

Study information

• Verified date: March 2016
• Source: Hospital Civil Juan I. Menchaca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Secretaria de Salud
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: March 2014
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia

Intervention

Dietary Supplement:
• L arginine
L arginine is a basic amino-acid precursor of nitric oxide main vasodilator.

Other:
• Placebo
calcined magnesia

Locations

Country	Name	City	State
Mexico	Panduro Baron J Guadalupe	Guadalajara	Jalisco

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Civil Juan I. Menchaca

Country where clinical trial is conducted

Mexico, 

References & Publications (2)

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. Review. — View 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 ri — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes
Secondary	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	Yes
Secondary	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	Yes