Respiratory Outcome of Children From the FEPED Cohort

Asthma in Children Clinical Trial

— RESPIFEPED  

Official title:

Respiratory Outcome According to Early Maternal Vitamin D Status During Pregnancy in Children Aged 5 to 6 Years Old

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03229317
• Other study ID #: K160907J
• Secondary ID: 2017-A01193-50
• Status: Completed
• Start date: January 31, 2018
• Est. completion date: December 16, 2020

Study information

• Verified date: April 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: December 16, 2020
• Est. primary completion date: December 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma in Children

Intervention

Other:
• Plethysmography
Lung plethysmography

Locations

Country	Name	City	State
France	Armand Trousseau Hospital	Paris
France	Necker Enfants-malades Hospital	Paris
France	Robert Debré Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (7)

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. — View Citation

Chawes BL, Bønnelykke K, Stokholm J, Vissing NH, Bjarnadóttir E, Schoos AM, Wolsk HM, Pedersen TM, Vinding RK, Thorsteinsdóttir 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. — View 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. — View Citation

Lange P, Celli B, Agustí 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. — View 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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Interrupter airway resistance measured by the interrupter technique using a pneumotachograph	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	1 day
Secondary	Residual functional capacity measured by the helium dilution technique	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	1 day
Secondary	Occurrence of one wheezing episode		1 day
Secondary	Age of the first wheezing episode		1 day
Secondary	Occurrence of Asthma at age 3 years old		1 day
Secondary	Occurrence of Asthma at age 5 or 6 years old		1 day
Secondary	Allergenic sensitizations determined by skin prick-tests		1 day
Secondary	Genotype of 4 single nucleotide polymorphisms related to vitamin D metabolism		1 day