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

Primary Purpose

Fetal Growth Retardation

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
L-arginine 3g + L-Citruline 2 g
Placebo
Sponsored by
Hospital Civil de Guadalajara
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fetal Growth Retardation focused on measuring L-arginine, l-Citruline, Fetal growth, percentile,

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

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

    placebo

    Arm Description

    Drug: L-arginine 3g and L-citruline 2g, Food supplement, PO , for 24 h, until birth

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

    Outcomes

    Primary Outcome Measures

    Fetal Growth
    fetal weight gain

    Secondary Outcome Measures

    Full Information

    First Posted
    August 25, 2021
    Last Updated
    August 27, 2021
    Sponsor
    Hospital Civil de Guadalajara
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05029778
    Brief Title
    Arginine + Citrulline as a Supplement for Weight Gain in Fetus With a Decrease in Their Growth Curve
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 20, 2021 (Anticipated)
    Primary Completion Date
    October 20, 2021 (Anticipated)
    Study Completion Date
    January 20, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hospital Civil de Guadalajara

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Fetal Growth Retardation
    Keywords
    L-arginine, l-Citruline, Fetal growth, percentile,

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Model Description
    Clinical Trial open controlled parallel randomized simple
    Masking
    ParticipantInvestigator
    Masking Description
    we don´t know who receives the intervention and who receives the placebo
    Allocation
    Randomized
    Enrollment
    41 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental L-arginine 3 g and L-citruline 2 g
    Arm Type
    Experimental
    Arm Description
    Drug: L-arginine 3g and L-citruline 2g, Food supplement, PO , for 24 h, until birth
    Arm Title
    placebo
    Arm Type
    Experimental
    Arm Description
    Placebo 3g ( starch ) PO for 24 h. until birth
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    L-arginine 3g + L-Citruline 2 g
    Other Intervention Name(s)
    L-arginine 3g, L-Citruline 2 g
    Intervention Description
    receive L-arginine 3g + l-Citruline 2 g PO, for 24 h, until birth.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    receive placebo 3g PO, for 24 h, until birth.
    Primary Outcome Measure Information:
    Title
    Fetal Growth
    Description
    fetal weight gain
    Time Frame
    10 weeks

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    single pregnancy in third trimester with fetus between the 10th to 25th percentile
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jorge Bravo Rubio, Dr
    Phone
    3221186759
    Email
    naranjo125@hotmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Maria Campechano Ascencio, Dra
    Phone
    3310233983
    Email
    angelescampechano@hotmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Milton Omar Guzman Ornelas, Dr.
    Organizational Affiliation
    University of Guadalajara
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    19768178
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    19786331
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    19562567
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    26865647
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    19941706
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    9364597
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    27003763
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    27528012
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    29998808
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    28090634
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    29422215
    Citation
    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.
    Results Reference
    result

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

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