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Respiratory Outcome of Children From the FEPED Cohort (RESPIFEPED)

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ClinicalTrials.gov Identifier: NCT03229317
Recruitment Status : Recruiting
First Posted : July 25, 2017
Last Update Posted : March 15, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
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.

Condition or disease Intervention/treatment
Asthma in Children Other: Plethysmography

Detailed Description:
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.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Respiratory Outcome According to Early Maternal Vitamin D Status During Pregnancy in Children Aged 5 to 6 Years Old
Actual Study Start Date : January 31, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D


Intervention Details:
  • Other: Plethysmography
    Lung plethysmography


Primary Outcome Measures :
  1. Specific airway resistance measured by plethysmography [ Time Frame: 1 day ]
    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


Secondary Outcome Measures :
  1. Interrupter airway resistance measured by the interrupter technique using a pneumotachograph [ Time Frame: 1 day ]
    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

  2. Residual functional capacity measured by the helium dilution technique [ Time Frame: 1 day ]
    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

  3. Occurrence of one wheezing episode [ Time Frame: 1 day ]
  4. Age of the first wheezing episode [ Time Frame: 1 day ]
  5. Occurrence of Asthma at age 3 years old [ Time Frame: 1 day ]
  6. Occurrence of Asthma at age 5 or 6 years old [ Time Frame: 1 day ]
  7. Allergenic sensitizations determined by skin prick-tests [ Time Frame: 1 day ]
  8. Genotype of 4 single nucleotide polymorphisms related to vitamin D metabolism [ Time Frame: 1 day ]


Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
term-born child (gestational age ≥ 37 weeks of post-menstrual age) whose mother was included in the FEPED cohort, with measure of vitamin D concentration available at the first and third trimester of pregnancy and in cord blood
Criteria

Inclusion Criteria:

  • term-born child (gestational age ≥ 37 weeks of post-menstrual age) whose mother was included in the FEPED cohort
  • measure of vitamin D concentration available at the first and third trimester of pregnancy and in cord blood
  • cord blood sample available for DNA extraction
  • child's age between 5 and 6 years old at the time of participation
  • written informed consent obtained from the legal guardian of the child
  • health insurance

Exclusion Criteria:

  • parent's' refusal
  • underlying disease that does not allow the performance of lung function tests

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03229317


Contacts
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Contact: Adèle BELLINO, Master 01.58.41.11.95 adèle.bellino@aphp.fr

Locations
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France
Armand Trousseau Hospital Recruiting
Paris, France, 75012
Contact: Nicole BEYDON, MD, PhD    01 71 73 85 18    nicole.beydon@aphp.fr   
Necker Enfants-malades Hospital Recruiting
Paris, France, 75015
Contact: Alice HADCHOUEL, MD, PhD    +33 1 44 49 48 47    alice.hadchouel-duverge@aphp.fr   
Robert Debré Hospital Not yet recruiting
Paris, France, 75019
Contact: Véronique HOUDOUIN, MD;, PhD    01 40 03 36 78    veronique.houdouin@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Alice HADCHOUEL, MD, PhD Assistance Publique - Hôpitaux de Paris
Study Chair: Alexandra BENACHI, MD, PhD Assistance Publique - Hôpitaux de Paris

Publications:

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03229317     History of Changes
Other Study ID Numbers: K160907J
2017-A01193-50 ( Other Identifier: IDRCB )
First Posted: July 25, 2017    Key Record Dates
Last Update Posted: March 15, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Lung function
Children
Vitamin D
COPD

Additional relevant MeSH terms:
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Vitamin D
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents