Respiratory Outcome of Children From the FEPED Cohort

NCT ID: NCT03229317

Last Updated: 2026-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

142 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-31

Study Completion Date

2020-12-16

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Asthma in Children

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Plethysmography

Lung plethysmography

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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URC-CIC Paris Descartes Necker Cochin

OTHER

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alice HADCHOUEL, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Alexandra BENACHI, MD, PhD

Role: STUDY_CHAIR

Assistance Publique - Hôpitaux de Paris

Locations

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Armand Trousseau Hospital

Paris, Paris, France

Site Status

Necker Enfants-malades Hospital

Paris, Paris, France

Site Status

Robert Debré Hospital

Paris, Paris, France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 26813208 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26813209 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28285844 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26399470 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26154786 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25123778 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24606581 (View on PubMed)

Gonsard A, Marquant F, Elie C, Le Bourgeois M, Houdouin V, Delclaux C, Beydon N, Bellino A, Souberbielle JC, Sermet-Gaudelus I, Delacourt C, Benachi A, Hadchouel A. Specific airway resistance according to early maternal vitamin D status during pregnancy in children aged 5 to 6 years old from the FEPED cohort (RESPIFEPED). Eur J Pediatr. 2025 Feb 5;184(2):176. doi: 10.1007/s00431-024-05954-0.

Reference Type RESULT
PMID: 39907821 (View on PubMed)

Other Identifiers

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2017-A01193-50

Identifier Type: OTHER

Identifier Source: secondary_id

K160907J

Identifier Type: -

Identifier Source: org_study_id

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