drugset / Trial / NCT00549575

L-Arginine Treatment for Severe Vascular Fetal Intrauterine Growth Restriction: a Randomized Double Bind Controlled Trial (L Arginine in IUGR)

NCT00549575 ↗

Phase 3 Terminated 44 enrolled Nantes University Hospital
RandomizedParallel-groupQuadruple-blindPrevention

Summary

Although there is a strong rationale to supplement gravid patients suffering intrauterine growth restriction (IUGR) or preeclampsia with Arginine or other nitric oxide donors, evidence in the literature has been inconclusive. The current study was designed to determine whether oral treatment with L-Arginine, a nitric oxide (NO) donor, would enhance birth weight and/or decrease neonatal morbidity in pregnancies with severe vascular intrauterine growth restriction (IUGR).

Timeline

Start
2000-07
Primary completion
—
Completion
2006-06

Outcome

Missed primary endpoint

Stopped: “terminated”

paper There was no significant difference between the two groups concerning birth weight (1042+/-476 vs. 1068+/-452 g). PMID 19359073 ↗

paper L-arginine is not an effective treatment for severe vascular growth restriction. PMID 19359073 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject ARGININE Small molecule 14 g Oral