Efficacy and Safety of L Arginine to Prevent Preeclampsia

NCT ID: NCT02363348

Last Updated: 2016-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2014-03-31

Brief Summary

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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

Detailed Description

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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

Conditions

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Preeclampsia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

calcined magnesia

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.

Group Type EXPERIMENTAL

L arginine

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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L arginine

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

calcined magnesia

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hospital Civil Juan I. Menchaca

OTHER

Sponsor Role lead

Responsible Party

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Eva Elizabet Camarena Pulido

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Guadalupe Panduro, Ph

Role: STUDY_CHAIR

Hospital Civil Juan I. Menchaca

Locations

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Panduro Baron J Guadalupe

Guadalajara, Jalisco, Mexico

Site Status

Countries

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Mexico

References

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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.

Reference Type BACKGROUND
PMID: 24313856 (View on PubMed)

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.

Reference Type RESULT
PMID: 21596735 (View on PubMed)

Other Identifiers

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SSJ1054-11

Identifier Type: -

Identifier Source: org_study_id

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