Efficacy and Safety of L Arginine to Prevent Preeclampsia

NCT02363348 | Completed Phase 3 DMC

• 1 other identifier: SSJ1054-11
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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

Conditions

Preeclampsia

Keywords

L arginine; Preeclampsia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• perinatal outcome

  from time to delivery until two weeks after, approximalety 18 weeks

• safety of L arginine

  from time of randomization until birth approximalety 18 weeks

Study Arms (2)

Placebo (A)

PLACEBO COMPARATOR

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

L arginine (B)

EXPERIMENTAL

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

Interventions

L arginine DIETARY_SUPPLEMENT

L arginine is a basic amino-acid precursor of nitric oxide main vasodilator.

L arginine (B)

Placebo OTHER

calcined magnesia

Placebo (A)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• one or more risk factors for developing preeclampsia (nulliparous, previous history of preeclampsia, chronic hypertension, BMI ≥30)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hospital Civil Juan I. Menchaca: lead

Study Sites (1)

Panduro Baron J Guadalupe

Guadalajara, Jalisco, 44340, Mexico

Location

Related 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.

  PMID: 24313856 BACKGROUND

• 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.

  PMID: 21596735 RESULT

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Arginine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Essential

Study Officials

• Guadalupe Panduro, Ph

  Hospital Civil Juan I. Menchaca

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 27, 2015
• First Posted: February 16, 2015
• Study Start: August 1, 2010
• Primary Completion: August 1, 2013
• Study Completion: March 1, 2014
• Last Updated: March 4, 2016

Record last verified: 2016-03

Locations

ME (1)