Asthma, In Utero Nicotine, Pulmonary Function, Wheezing
Conditions
Keywords
Asthma, Pulmonary Function, Pulmonary Function Testing, Wheeze, Vitamin C, Antioxidants, Forced Expiratory Flows, Spirometry, Lung Function, Epigenetics, High resolution CT scans
Brief summary
The overall aims of this protocol are to determine whether prenatal supplementation with vitamin C to pregnant smokers can improve pulmonary function at 10 years of age in their offspring. This is an additional continuation of the Vitamin C to Decrease Effects of Smoking in Pregnancy on Infant Lung Function (VCSIP) trial, to follow the offspring through 10 years of age. The hypothesis for this protocol is an extension of the VCSIP trial that supplemental vitamin C in pregnant smokers can significantly improve their children's airway function tests. The investigators aim to demonstrate sustained improvement in airway/pulmonary function and trajectory through 10 years of age.
Detailed description
The primary outcome of this longitudinal follow-up study is the comparison of airway function tests (specifically the forced expiratory flow between 25%and 75% of expired volume \[FEF25-75\]) measured yearly through 10 years of age by forced expiratory maneuvers with spirometry between the children of the pregnant smokers randomized to vitamin C (500 mg/day) versus placebo during pregnancy. The occurrence of wheeze obtained with quarterly standardized respiratory questionnaires will also be compared between the two groups of children. This is a follow-up of the original Vitamin C to Decrease Effects of Smoking in Pregnancy on Infant Lung Function (VCSIP) trial. The secondary outcomes are: 1. A single low dose high-resolution computed tomography (HRCT) image of the lungs (acquired during inspiration) will be done at 10 years of age in offspring of pregnant smokers who were randomized to vitamin C (500 mg/day) versus placebo during pregnancy. Image analysis will be performed by Dr. Miranda Kirby's Quantitative Image Analysis in Medicine laboratory at Ryerson University in Toronto, ON using certified pulmonary image analysis software. The airway lumen cross sectional areas to at least the fifth generation of airways will be compared between the two groups of children. The number of airways and the lumen, wall, and total cross sectional areas and the segment lengths will also be quantified. 2. A secondary aim is to quantify the differences in DNA methylation between the two groups and measure the correlation between the differences in DNA methylation and respiratory outcomes.
Interventions
OTHERNo active intervention in this protocol (previously randomized to Placebo)
In the original VCSIP study, pregnant women were randomized to receive either extra Vitamin C every day (500mg/day) or placebo. This trial is a follow-up trial with no active intervention.
DIETARY_SUPPLEMENTNo active intervention in this protocol (previously randomized to Vitamin C)
In the original VCSIP study, pregnant women were randomized to receive either extra Vitamin C every day (500mg/day) or placebo. This trial is a follow-up trial with no active intervention.
Sponsors
Indiana University
National Heart, Lung, and Blood Institute (NHLBI)
Oregon Health and Science University
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
* Women and their offspring randomized to vitamin C versus placebo during pregnancy as well as pregnant nonsmokers and their offspring enrolled as the reference group in the original VCSIP study
Exclusion criteria
* participants who specifically withdraw consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sustained improvement in pulmonary function and trajectory | 10 years of age | The primary outcome of this longitudinal follow-up study is the comparison of airway function tests (specifically FEF25-75 in liters/sec) measured yearly through 10 years of age by forced expiratory maneuvers with spirometry between the children of the pregnant smokers randomized to vitamin C (500 mg/day) versus placebo during pregnancy. This is a follow-up of the original Vitamin C to Decrease Effects of Smoking in Pregnancy on Infant Lung Function (VCSIP) trial. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of wheeze | 10 years of age | The occurrence of wheeze obtained with quarterly standardized respiratory questionnaires will also be compared between the children of the pregnant smokers randomized to vitamin C (500 mg/day) versus placebo during pregnancy. This is a follow-up of the original Vitamin C to Decrease Effects of Smoking in Pregnancy on Infant Lung Function (VCSIP) trial. |
| Airway lumen cross sectional areas | 10 years of age | A single low dose high-resolution computed tomography (HRCT) image of the lungs (acquired during inspiration) will be done at 10 years of age in offspring of pregnant smokers who were randomized to vitamin C (500 mg/day) versus placebo during pregnancy. Image analysis will be performed by Dr. Miranda Kirby's Quantitative Image Analysis in Medicine laboratory at Ryerson University in Toronto, ON using certified pulmonary image analysis software. The airway lumen cross sectional areas (in mm squared) to at least the fifth generation of airways will be compared between the two groups of children. |
| Changes in DNA methylation | 10 years of age | A secondary aim is to quantify the differences in DNA methylation between the two groups and measure the correlation between the differences in DNA methylation and respiratory outcomes. |
Countries
United States
Contacts
Primary ContactCindy McEvoy, MD, MCR
Backup ContactKristin Milner, BS, CMA, CCRP
Outcome results
None listed