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

NCT05029778 | Unknown Phase 4 DMC

• 1 other identifier: 097/20
• Study Type: interventional
• Target: 41
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Fetal Growth Retardation

Keywords

L-arginine, l-Citruline, Fetal growth, percentile,

Outcome Measures

Primary Outcomes (1)

• Fetal Growth

  fetal weight gain

  10 weeks

Study Arms (2)

Experimental L-arginine 3 g and L-citruline 2 g

EXPERIMENTAL

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

placebo

EXPERIMENTAL

Placebo 3g ( starch ) PO for 24 h. until birth

Drug: Placebo

Interventions

L-arginine 3g + L-Citruline 2 g DIETARY_SUPPLEMENT

receive L-arginine 3g + l-Citruline 2 g PO, for 24 h, until birth.

Also known as: L-arginine 3g, L-Citruline 2 g

Experimental L-arginine 3 g and L-citruline 2 g

Placebo DRUG

receive placebo 3g PO, for 24 h, until birth.

placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: single pregnancy in third trimester with fetus between the 10th to 25th percentile
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 .

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Civil de Guadalajara: lead

Related Publications (11)

• Dover GJ. The Barker hypothesis: how pediatricans will diagnose and prevent common adult-onset diseases. Trans Am Clin Climatol Assoc. 2009;120:199-207. No abstract available.

  PMID: 19768178 BACKGROUND

• Ananth CV, Vintzileos AM. Distinguishing pathological from constitutional small for gestational age births in population-based studies. Early Hum Dev. 2009 Oct;85(10):653-8. doi: 10.1016/j.earlhumdev.2009.09.004. Epub 2009 Sep 27.

  PMID: 19786331 RESULT

• Barker DJ, Osmond C, Kajantie E, Eriksson JG. Growth and chronic disease: findings in the Helsinki Birth Cohort. Ann Hum Biol. 2009 Sep-Oct;36(5):445-58. doi: 10.1080/03014460902980295.

  PMID: 19562567 RESULT

• Bourdon A, Parnet P, Nowak C, Tran NT, Winer N, Darmaun D. L-Citrulline Supplementation Enhances Fetal Growth and Protein Synthesis in Rats with Intrauterine Growth Restriction. J Nutr. 2016 Mar;146(3):532-41. doi: 10.3945/jn.115.221267. Epub 2016 Feb 10.

  PMID: 26865647 RESULT

• Bujold E, Morency AM, Roberge S, Lacasse Y, Forest JC, Giguere Y. Acetylsalicylic acid for the prevention of preeclampsia and intra-uterine growth restriction in women with abnormal uterine artery Doppler: a systematic review and meta-analysis. J Obstet Gynaecol Can. 2009 Sep;31(9):818-826. doi: 10.1016/S1701-2163(16)34300-6.

  PMID: 19941706 RESULT

• Byrne BM, Howard RB, Morrow RJ, Whiteley KJ, Adamson SL. Role of the L-arginine nitric oxide pathway in hypoxic fetoplacental vasoconstriction. Placenta. 1997 Nov;18(8):627-34. doi: 10.1016/s0143-4004(97)90003-5.

  PMID: 9364597 RESULT

• Camarena Pulido EE, Garcia Benavides L, Panduro Baron JG, Pascoe Gonzalez S, Madrigal Saray AJ, Garcia Padilla FE, Totsuka Sutto SE. Efficacy of L-arginine for preventing preeclampsia in high-risk pregnancies: A double-blind, randomized, clinical trial. Hypertens Pregnancy. 2016 May;35(2):217-25. doi: 10.3109/10641955.2015.1137586. Epub 2016 Mar 22.

  PMID: 27003763 RESULT

• Chen J, Gong X, Chen P, Luo K, Zhang X. Effect of L-arginine and sildenafil citrate on intrauterine growth restriction fetuses: a meta-analysis. BMC Pregnancy Childbirth. 2016 Aug 16;16:225. doi: 10.1186/s12884-016-1009-6.

  PMID: 27528012 RESULT

• Colella M, Frerot A, Novais ARB, Baud O. Neonatal and Long-Term Consequences of Fetal Growth Restriction. Curr Pediatr Rev. 2018;14(4):212-218. doi: 10.2174/1573396314666180712114531.

  PMID: 29998808 RESULT

• Cottrell E, Tropea T, Ormesher L, Greenwood S, Wareing M, Johnstone E, Myers J, Sibley C. Dietary interventions for fetal growth restriction - therapeutic potential of dietary nitrate supplementation in pregnancy. J Physiol. 2017 Aug 1;595(15):5095-5102. doi: 10.1113/JP273331. Epub 2017 Feb 27.

  PMID: 28090634 RESULT

• Crispi F, Miranda J, Gratacos E. Long-term cardiovascular consequences of fetal growth restriction: biology, clinical implications, and opportunities for prevention of adult disease. Am J Obstet Gynecol. 2018 Feb;218(2S):S869-S879. doi: 10.1016/j.ajog.2017.12.012.

  PMID: 29422215 RESULT

MeSH Terms

Conditions

Fetal Growth Retardation

Interventions

Arginine

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Essential

Study Officials

• Milton Omar Guzman Ornelas, Dr.

  University of Guadalajara

  STUDY DIRECTOR

Central Study Contacts

Jorge Bravo Rubio, Dr

CONTACT

3221186759; naranjo125@hotmail.com

Maria Campechano Ascencio, Dra

CONTACT

3310233983; angelescampechano@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: we don´t know who receives the intervention and who receives the placebo
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fetal and maternal medicine

Model Details: Clinical Trial open controlled parallel randomized simple

Study Record Dates

• First Submitted: August 25, 2021
• First Posted: September 1, 2021
• Study Start: October 20, 2021
• Primary Completion: October 20, 2021
• Study Completion: January 20, 2024
• Last Updated: September 1, 2021

Record last verified: 2021-08