NCT05029778

Arginine + Citrulline as a Supplement for Weight Gain in Fetus With a Decrease in Their Growth Curve

Status unknown Phase 4 Last updated 1 September 2021

What this trial tests

Phase 4 trial testing L-arginine 3g + L-Citruline 2 g in Fetal Growth Retardation in 41 participants. Status unknown.

Timeline

20 October 2021

Primary endpoint
20 October 2021

20 January 2024

Quick facts

Lead sponsor	Hospital Civil de Guadalajara
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	41
Start date	20 October 2021
Primary completion	20 October 2021
Estimated completion	20 January 2024

Drugs / interventions tested

• L-arginine 3g + L-Citruline 2 g
• Placebo

Conditions studied

• Fetal Growth Retardation — all drugs for Fetal Growth Retardation →

Sponsor

Hospital Civil de Guadalajara

Who can join

Adults 18 to 35, female only, with Fetal Growth Retardation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Introduction:

The high incidence of intrauterine growth restriction is a public health problem; in this pathology, newborns present weight below the 10th percentile, this implies an increase in morbidity in the short term (complications due to hypoxia) and long term (pathologies typical of Fetal Programming) as well as the cost of health services. L-arginine at different doses has been used for some pathologies such as preeclampsia with controversial results. Authors have mentioned that the joint administration of l-citrulline can increase the efficacy of l-arginine. A stunted fetus is a challenge for the fetal physician; due to the complexity of the follow-up, but above all to determine the moment for the termination of the pregnancy. Finding some treatment to promote weight gain would improve the short- and long-term expectations of these infants.

General objective To determine the efficacy of L-arginine + L-Citrulline (3 / 2g) every 24 hours, in fetuses with a decrease in their growth curve in the third trimester of pregnancy.

Material and methods Clinical trial, parallel, controlled, randomized simple, Double blind. Two groups of pregnant women will be carried out in the third trimester; fetus with a decrease in its growth curve, percentile\> 10 and \<25 for gestation age, they will be given an informed consent letter and they will be randomized (double blind), they will proceed to give intervention (L-arginine + Citrin (3 / 2 g) every 24 hours Vs placebo), a follow-up will be carried out every two weeks, where the weight and growth curve will be calculated in percentile, until the resolution of the pregnancy and data will be taken from the perinatal results in both groups.

Statistic analysis Medics of central tendency will be calculated and Chi squared will be applied for qualitative variables, T of student for qualitative variables and it is considered P \<0.005.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Interventions affecting the nitric oxide pathway versus placebo or no therapy for fetal growth restriction in pregnancy.
   Pels A, Ganzevoort W, Kenny LC, Baker PN, et al · · 2023 · cited 12× · PMID 37428872 · DOI 10.1002/14651858.cd014498