Respiratory Outcome of Children From the FEPED Cohort

NCT03229317 | Completed

• 2 other identifiers: K160907J2017-A01193-50
• Study Type: observational
• Target: 142
• Locations: 1 country
• Sites: 3

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.

Conditions

Asthma in Children

Keywords

Lung function; Children; Vitamin D; COPD

Outcome Measures

Primary Outcomes (1)

• Specific airway resistance measured by plethysmography

  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

  1 day

Secondary Outcomes (8)

• Interrupter airway resistance measured by the interrupter technique using a pneumotachograph

  1 day

• Residual functional capacity measured by the helium dilution technique

  1 day

• Occurrence of one wheezing episode

  1 day

• Age of the first wheezing episode

  1 day

• Occurrence of Asthma at age 3 years old

  1 day

Interventions

Plethysmography OTHER

Lung plethysmography

Eligibility Criteria

• Age: 5 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (3)

Armand Trousseau Hospital

Paris, Paris, 75012, France

Location

Necker Enfants-malades Hospital

Paris, Paris, 75015, France

Location

Robert Debré Hospital

Paris, Paris, 75019, France

Location

Related Publications (8)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 39907821 RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alice HADCHOUEL, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

• Alexandra BENACHI, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2017
• First Posted: July 25, 2017
• Study Start: January 31, 2018
• Primary Completion: December 16, 2020
• Study Completion: December 16, 2020
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)