<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03229317</url>
  </required_header>
  <id_info>
    <org_study_id>K160907J</org_study_id>
    <secondary_id>2017-A01193-50</secondary_id>
    <nct_id>NCT03229317</nct_id>
  </id_info>
  <brief_title>Respiratory Outcome of Children From the FEPED Cohort</brief_title>
  <acronym>RESPIFEPED</acronym>
  <official_title>Respiratory Outcome According to Early Maternal Vitamin D Status During Pregnancy in Children Aged 5 to 6 Years Old</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Early lung function deficits represent a significant risk factor for the evolution toward&#xD;
      chronic obstructive pulmonary disease later in life. Prematurity and in utero tobacco smoke&#xD;
      exposure are already known to predispose children to develop a non-reversible obstructive&#xD;
      ventilatory defect in adulthood. The role of vitamin D status during pregnancy is less&#xD;
      certain. In humans, low vitamin D concentrations during pregnancy are associated to an&#xD;
      increased risk of asthma in children. In murine models, low vitamin D concentrations during&#xD;
      pregnancy are associated to structural abnormalities of the airways in mouse pups.&#xD;
      Investigators hypothesized that vitamin D play a role in early airways development, from the&#xD;
      first trimester of pregnancy. To bring arguments to this hypothesis, the investigators will&#xD;
      study the association of airway resistance in children aged 5 to 6 years old with the&#xD;
      concentration of vitamin D during the first trimester of pregnancy in their mothers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Children aged 5 to 6 years old will be included from the FEPED cohort. The FEPED cohort is a&#xD;
      cohort of French pregnant women designed to study the association between vitamin D status&#xD;
      during pregnancy and the risk of pre-eclampsia. Vitamin D concentration at first and third&#xD;
      trimester of pregnancy as well as in cord blood is available for 1400 women. Investigators&#xD;
      will include 200 children born from these women. Children will undergo lung function tests&#xD;
      and prick-tests and parents will answer the ISAAC questionnaire that is a standardised&#xD;
      questionnaire designed to evaluate asthma and rhinitis symptoms. The main outcome of this&#xD;
      study will be specific airway resistance. The investigators will look for an association&#xD;
      between specific airway resistance and vitamin D concentration measured during the first&#xD;
      trimester of pregnancy in their mothers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 31, 2018</start_date>
  <completion_date type="Actual">December 16, 2020</completion_date>
  <primary_completion_date type="Actual">December 16, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Specific airway resistance measured by plethysmography</measure>
    <time_frame>1 day</time_frame>
    <description>The measure of this outcome will be compared between children with a concentration of vitamin D during the first trimester of pregnancy &lt; 20 ng/ml and children with a concentration ≥ 20 ng/ml</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Interrupter airway resistance measured by the interrupter technique using a pneumotachograph</measure>
    <time_frame>1 day</time_frame>
    <description>This secondary outcome is another way to measure airway resistance. The measure of this outcome will be also compared between children with a concentration of vitamin D during the first trimester of pregnancy &lt; 20 ng/ml and children with a concentration ≥ 20 ng/ml</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Residual functional capacity measured by the helium dilution technique</measure>
    <time_frame>1 day</time_frame>
    <description>This secondary outcome is another lung function parameter that will allow to evaluate lung volumes of the participants. The measure of this outcome will also be compared between children with a concentration of vitamin D during the first trimester of pregnancy &lt; 20 ng/ml and children with a concentration ≥ 20 ng/ml</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of one wheezing episode</measure>
    <time_frame>1 day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Age of the first wheezing episode</measure>
    <time_frame>1 day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of Asthma at age 3 years old</measure>
    <time_frame>1 day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of Asthma at age 5 or 6 years old</measure>
    <time_frame>1 day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Allergenic sensitizations determined by skin prick-tests</measure>
    <time_frame>1 day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Genotype of 4 single nucleotide polymorphisms related to vitamin D metabolism</measure>
    <time_frame>1 day</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">142</enrollment>
  <condition>Asthma in Children</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Plethysmography</intervention_name>
    <description>Lung plethysmography</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        term-born child (gestational age ≥ 37 weeks of post-menstrual age) whose mother was&#xD;
        included in the FEPED cohort, with measure of vitamin D concentration available at the&#xD;
        first and third trimester of pregnancy and in cord blood&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  term-born child (gestational age ≥ 37 weeks of post-menstrual age) whose mother was&#xD;
             included in the FEPED cohort&#xD;
&#xD;
          -  measure of vitamin D concentration available at the first and third trimester of&#xD;
             pregnancy and in cord blood&#xD;
&#xD;
          -  cord blood sample available for DNA extraction&#xD;
&#xD;
          -  child's age between 5 and 6 years old at the time of participation&#xD;
&#xD;
          -  written informed consent obtained from the legal guardian of the child&#xD;
&#xD;
          -  health insurance&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  parent's' refusal&#xD;
&#xD;
          -  underlying disease that does not allow the performance of lung function tests&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>6 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alice HADCHOUEL, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistance Publique - Hôpitaux de Paris</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Alexandra BENACHI, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Assistance Publique - Hôpitaux de Paris</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Armand Trousseau Hospital</name>
      <address>
        <city>Paris</city>
        <zip>75012</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Necker Enfants-malades Hospital</name>
      <address>
        <city>Paris</city>
        <zip>75015</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Robert Debré Hospital</name>
      <address>
        <city>Paris</city>
        <zip>75019</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>Chawes BL, Bonnelykke K, Stokholm J, Vissing NH, Bjarnadottir E, Schoos AM, Wolsk HM, Pedersen TM, Vinding RK, Thorsteinsdottir S, Arianto L, Hallas HW, Heickendorff L, Brix S, Rasmussen MA, Bisgaard H. Effect of Vitamin D3 Supplementation During Pregnancy on Risk of Persistent Wheeze in the Offspring: A Randomized Clinical Trial. JAMA. 2016 Jan 26;315(4):353-61. doi: 10.1001/jama.2015.18318.</citation>
    <PMID>26813208</PMID>
  </reference>
  <reference>
    <citation>Litonjua AA, Carey VJ, Laranjo N, Harshfield BJ, McElrath TF, O'Connor GT, Sandel M, Iverson RE Jr, Lee-Paritz A, Strunk RC, Bacharier LB, Macones GA, Zeiger RS, Schatz M, Hollis BW, Hornsby E, Hawrylowicz C, Wu AC, Weiss ST. Effect of Prenatal Supplementation With Vitamin D on Asthma or Recurrent Wheezing in Offspring by Age 3 Years: The VDAART Randomized Clinical Trial. JAMA. 2016 Jan 26;315(4):362-70. doi: 10.1001/jama.2015.18589.</citation>
    <PMID>26813209</PMID>
  </reference>
  <reference>
    <citation>Wolsk HM, Harshfield BJ, Laranjo N, Carey VJ, O'Connor G, Sandel M, Strunk RC, Bacharier LB, Zeiger RS, Schatz M, Hollis BW, Weiss ST, Litonjua AA. Vitamin D supplementation in pregnancy, prenatal 25(OH)D levels, race, and subsequent asthma or recurrent wheeze in offspring: Secondary analyses from the Vitamin D Antenatal Asthma Reduction Trial. J Allergy Clin Immunol. 2017 Nov;140(5):1423-1429.e5. doi: 10.1016/j.jaci.2017.01.013. Epub 2017 Mar 9.</citation>
    <PMID>28285844</PMID>
  </reference>
  <reference>
    <citation>Gazibara T, den Dekker HT, de Jongste JC, McGrath JJ, Eyles DW, Burne TH, Reiss IK, Franco OH, Tiemeier H, Jaddoe VW, Duijts L. Associations of maternal and fetal 25-hydroxyvitamin D levels with childhood lung function and asthma: the Generation R Study. Clin Exp Allergy. 2016 Feb;46(2):337-46. doi: 10.1111/cea.12645.</citation>
    <PMID>26399470</PMID>
  </reference>
  <reference>
    <citation>Lange P, Celli B, Agusti A, Boje Jensen G, Divo M, Faner R, Guerra S, Marott JL, Martinez FD, Martinez-Camblor P, Meek P, Owen CA, Petersen H, Pinto-Plata V, Schnohr P, Sood A, Soriano JB, Tesfaigzi Y, Vestbo J. Lung-Function Trajectories Leading to Chronic Obstructive Pulmonary Disease. N Engl J Med. 2015 Jul 9;373(2):111-22. doi: 10.1056/NEJMoa1411532.</citation>
    <PMID>26154786</PMID>
  </reference>
  <reference>
    <citation>Postma DS, Bush A, van den Berge M. Risk factors and early origins of chronic obstructive pulmonary disease. Lancet. 2015 Mar 7;385(9971):899-909. doi: 10.1016/S0140-6736(14)60446-3. Epub 2014 Aug 11.</citation>
    <PMID>25123778</PMID>
  </reference>
  <reference>
    <citation>Belgrave DC, Buchan I, Bishop C, Lowe L, Simpson A, Custovic A. Trajectories of lung function during childhood. Am J Respir Crit Care Med. 2014 May 1;189(9):1101-9. doi: 10.1164/rccm.201309-1700OC.</citation>
    <PMID>24606581</PMID>
  </reference>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>July 3, 2017</study_first_submitted>
  <study_first_submitted_qc>July 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 25, 2017</study_first_posted>
  <last_update_submitted>April 30, 2021</last_update_submitted>
  <last_update_submitted_qc>April 30, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Lung function</keyword>
  <keyword>Children</keyword>
  <keyword>Vitamin D</keyword>
  <keyword>COPD</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03229317
org study id: K160907J
secondary id: 2017-A01193-50
nct id: NCT03229317
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Early lung function deficits represent a significant risk factor for the evolution toward
      chronic obstructive pulmonary disease later in life. Prematurity and in utero tobacco smoke
      exposure are already known to predispose children to develop a non-reversible obstructive
      ventilatory defect in adulthood. The role of vitamin D status during pregnancy is less
      certain. In humans, low vitamin D concentrations during pregnancy are associated to an
      increased risk of asthma in children. In murine models, low vitamin D concentrations during
      pregnancy are associated to structural abnormalities of the airways in mouse pups.
      Investigators hypothesized that vitamin D play a role in early airways development, from the
      first trimester of pregnancy. To bring arguments to this hypothesis, the investigators will
      study the association of airway resistance in children aged 5 to 6 years old with the
      concentration of vitamin D during the first trimester of pregnancy in their mothers.
Children aged 5 to 6 years old will be included from the FEPED cohort. The FEPED cohort is a
      cohort of French pregnant women designed to study the association between vitamin D status
      during pregnancy and the risk of pre-eclampsia. Vitamin D concentration at first and third
      trimester of pregnancy as well as in cord blood is available for 1400 women. Investigators
      will include 200 children born from these women. Children will undergo lung function tests
      and prick-tests and parents will answer the ISAAC questionnaire that is a standardised
      questionnaire designed to evaluate asthma and rhinitis symptoms. The main outcome of this
      study will be specific airway resistance. The investigators will look for an association
      between specific airway resistance and vitamin D concentration measured during the first
      trimester of pregnancy in their mothers.
observational model: Cohort
time perspective: Prospective
measure: Specific airway resistance measured by plethysmography
time frame: 1 day
description: The measure of this outcome will be compared between children with a concentration of vitamin D during the first trimester of pregnancy < 20 ng/ml and children with a concentration ≥ 20 ng/ml
measure: Interrupter airway resistance measured by the interrupter technique using a pneumotachograph
time frame: 1 day
description: This secondary outcome is another way to measure airway resistance. The measure of this outcome will be also compared between children with a concentration of vitamin D during the first trimester of pregnancy < 20 ng/ml and children with a concentration ≥ 20 ng/ml
measure: Residual functional capacity measured by the helium dilution technique
time frame: 1 day
description: This secondary outcome is another lung function parameter that will allow to evaluate lung volumes of the participants. The measure of this outcome will also be compared between children with a concentration of vitamin D during the first trimester of pregnancy < 20 ng/ml and children with a concentration ≥ 20 ng/ml
measure: Occurrence of one wheezing episode
time frame: 1 day
measure: Age of the first wheezing episode
time frame: 1 day
measure: Occurrence of Asthma at age 3 years old
time frame: 1 day
measure: Occurrence of Asthma at age 5 or 6 years old
time frame: 1 day
measure: Allergenic sensitizations determined by skin prick-tests
time frame: 1 day
measure: Genotype of 4 single nucleotide polymorphisms related to vitamin D metabolism
time frame: 1 day
intervention type: Other
intervention name: Plethysmography
description: Lung plethysmography
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 5 Years
maximum age: 6 Years
healthy volunteers: No
last name: Alice HADCHOUEL, MD, PhD
role: Principal Investigator
affiliation: Assistance Publique - Hôpitaux de Paris
last name: Alexandra BENACHI, MD, PhD
role: Study Chair
affiliation: Assistance Publique - Hôpitaux de Paris
facility: 
facility: 
facility: 
country: France
citation: Chawes BL, Bonnelykke K, Stokholm J, Vissing NH, Bjarnadottir E, Schoos AM, Wolsk HM, Pedersen TM, Vinding RK, Thorsteinsdottir S, Arianto L, Hallas HW, Heickendorff L, Brix S, Rasmussen MA, Bisgaard H. Effect of Vitamin D3 Supplementation During Pregnancy on Risk of Persistent Wheeze in the Offspring: A Randomized Clinical Trial. JAMA. 2016 Jan 26;315(4):353-61. doi: 10.1001/jama.2015.18318.
PMID: 26813208
citation: Litonjua AA, Carey VJ, Laranjo N, Harshfield BJ, McElrath TF, O'Connor GT, Sandel M, Iverson RE Jr, Lee-Paritz A, Strunk RC, Bacharier LB, Macones GA, Zeiger RS, Schatz M, Hollis BW, Hornsby E, Hawrylowicz C, Wu AC, Weiss ST. Effect of Prenatal Supplementation With Vitamin D on Asthma or Recurrent Wheezing in Offspring by Age 3 Years: The VDAART Randomized Clinical Trial. JAMA. 2016 Jan 26;315(4):362-70. doi: 10.1001/jama.2015.18589.
PMID: 26813209
citation: Wolsk HM, Harshfield BJ, Laranjo N, Carey VJ, O'Connor G, Sandel M, Strunk RC, Bacharier LB, Zeiger RS, Schatz M, Hollis BW, Weiss ST, Litonjua AA. Vitamin D supplementation in pregnancy, prenatal 25(OH)D levels, race, and subsequent asthma or recurrent wheeze in offspring: Secondary analyses from the Vitamin D Antenatal Asthma Reduction Trial. J Allergy Clin Immunol. 2017 Nov;140(5):1423-1429.e5. doi: 10.1016/j.jaci.2017.01.013. Epub 2017 Mar 9.
PMID: 28285844
citation: Gazibara T, den Dekker HT, de Jongste JC, McGrath JJ, Eyles DW, Burne TH, Reiss IK, Franco OH, Tiemeier H, Jaddoe VW, Duijts L. Associations of maternal and fetal 25-hydroxyvitamin D levels with childhood lung function and asthma: the Generation R Study. Clin Exp Allergy. 2016 Feb;46(2):337-46. doi: 10.1111/cea.12645.
PMID: 26399470
citation: Lange P, Celli B, Agusti A, Boje Jensen G, Divo M, Faner R, Guerra S, Marott JL, Martinez FD, Martinez-Camblor P, Meek P, Owen CA, Petersen H, Pinto-Plata V, Schnohr P, Sood A, Soriano JB, Tesfaigzi Y, Vestbo J. Lung-Function Trajectories Leading to Chronic Obstructive Pulmonary Disease. N Engl J Med. 2015 Jul 9;373(2):111-22. doi: 10.1056/NEJMoa1411532.
PMID: 26154786
citation: Postma DS, Bush A, van den Berge M. Risk factors and early origins of chronic obstructive pulmonary disease. Lancet. 2015 Mar 7;385(9971):899-909. doi: 10.1016/S0140-6736(14)60446-3. Epub 2014 Aug 11.
PMID: 25123778
citation: Belgrave DC, Buchan I, Bishop C, Lowe L, Simpson A, Custovic A. Trajectories of lung function during childhood. Am J Respir Crit Care Med. 2014 May 1;189(9):1101-9. doi: 10.1164/rccm.201309-1700OC.
PMID: 24606581
responsible party type: Sponsor
sharing ipd: No