Efficacy and Safety of L Arginine to Prevent Preeclampsia

Hospital Civil Juan I. Menchaca

Status and phase: Completed; Phase 3

Conditions: Preeclampsia

Treatments: Dietary Supplement: L arginine; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02363348

SSJ1054-11

Details and patient eligibility

About

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

Full 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

Enrollment: 96 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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96 participants in 2 patient groups, including a placebo group

Placebo (A)

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo

L arginine (B)

Experimental group

Description:

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.

Treatment:

Dietary Supplement: L arginine