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Completed

NCT Number: NCT03229317

Respiratory Outcome of Children From the FEPED Cohort

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.

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Key information

Conditions

Asthma in Children Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

5 year–6 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Armand Trousseau Hospital, Paris, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

plethysmography

Other

Lung plethysmography

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

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

Acronym: RESPIFEPED

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 25, 2017
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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