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

August 27, 2021 updated by: Jorge Bravo Rubio, Hospital Civil de Guadalajara

Efficacy L-arginine + L-citrulline as a Dietary Supplement vs Placebo for Weight Gain in Fetus With a Decrease in Their Growth Curve in the Third Trimester of Pregnancy

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

50 patients with a pregnancy of more than 26 weeks of gestation, 25 with intervention and 25 control will be included; in which the fetus is between 10 and 25th percentile . It will be carried out in the obstetric service of the old civil hospital, with a double-blind randomization.

Evaluations will be carried out every two weeks where the fetal weight, umbilical artery Doppler, middle cerebral artery, venous duct, uterine arteries, amniotic fluid, placenta will be evaluated.

The assessment will be made until birth, from where the birth weight, height, Apgar, Capurro score, characteristics and placental weight, approximate bleeding will be collected.

Study Type

Interventional

Enrollment (Anticipated)

41

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Pregnancy with a single fetus
  • Patient over 18 years of age
  • Patient under 35 years of age
  • Pregnancy greater than 25 weeks' gestation confirmed by first trimester ultrasound or reliable last period
  • Fetus with decrease or flattening of its growth curve by ultrasound (P> 10 and <25)
  • Apparently healthy fetus
  • Fetus without Doppler alterations in any of its blood vessels (Venous Ductus, Cerebral Artery medial, Umbilical Artery .

Exclusion Criteria:

  • Fetus diagnosed with a malformation
  • Fetus diagnosed with a syndrome or chromosomopathy
  • Fetus below the 10th percentile for gestational age by ultrasound
  • Mother with Type 1, Type 2 or Gestational Diabetes mellitus.
  • Chronic maternal hypertension
  • Preeclampsia with data of severity or early onset
  • Aspirin intake (100-150 mg a day from the first trimester of pregnancy)
  • Fetus with a poor ultrasonographic window for evaluation.
  • Mother with BMI <18.5 prior to pregnancy
  • Maternal BMI> 30
  • Known allergy to treatment
  • Non-reassuring fetal state.
  • Abnormal placental insertion.
  • Patient with renal insufficiency, LUPUS or Antiphospholipid syndrome

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental L-arginine 3 g and L-citruline 2 g
Drug: L-arginine 3g and L-citruline 2g, Food supplement, PO , for 24 h, until birth
Dietary supplement: L-arginine 3g + L-Citruline 2 g
receive L-arginine 3g + l-Citruline 2 g PO, for 24 h, until birth.
Other Names:
  • L-arginine 3g
  • L-Citruline 2 g
Experimental: placebo
Placebo 3g ( starch ) PO for 24 h. until birth
Drug: Placebo
receive placebo 3g PO, for 24 h, until birth.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fetal Growth
Time Frame: 10 weeks
fetal weight gain
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Civil de Guadalajara

Investigators

  • Study Director: Milton Omar Guzman Ornelas, Dr., University of Guadalajara

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 20, 2021

Primary Completion (Anticipated)

October 20, 2021

Study Completion (Anticipated)

January 20, 2024

Study Registration Dates

First Submitted

August 25, 2021

First Submitted That Met QC Criteria

August 27, 2021

First Posted (Actual)

September 1, 2021

Study Record Updates

Last Update Posted (Actual)

September 1, 2021

Last Update Submitted That Met QC Criteria

August 27, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 097/20

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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