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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03206710
Other study ID # VCSIP ECHO
Secondary ID UG3OD023288
Status Recruiting
Phase
First received
Last updated
Start date June 1, 2017
Est. completion date December 1, 2024

Study information

Verified date April 2024
Source Oregon Health and Science University
Contact Cindy McEvoy, MD, MCR
Phone 503-494-0085
Email mcevoyc@ohsu.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In a randomized clinical trial (RCT) published in JAMA, the investigators have provided evidence that vitamin C supplementation (500 mg daily during pregnancy) ameliorates the effects of maternal smoking during pregnancy on offspring lung function and subsequent incidence of wheeze by 48% through 1 year of age. The investigators are currently completing a second RCT of vitamin C supplementation in pregnant smokers with more robust measures of pulmonary outcomes. The purpose of this ECHO application is to combine these 2 focused, interventional cohorts to allow critical longitudinal follow-up of respiratory outcomes in these children including the study of pulmonary function test (PFT) trajectories and incidence of recurrent wheeze/asthma from infancy through early adolescence in offspring of pregnant smokers randomized to vitamin C versus placebo.


Description:

In a randomized clinical trial (RCT) published in JAMA, the investigators have provided evidence that vitamin C supplementation (500 mg daily during pregnancy) ameliorates the effects of maternal smoking during pregnancy on offspring lung function and subsequent incidence of wheeze by 48% through 1 year of age. the investigators are currently completing a second RCT of vitamin C supplementation in pregnant smokers with more robust measures of pulmonary outcomes. The purpose of this ECHO application is to combine these 2 focused, interventional cohorts to allow critical longitudinal follow-up of respiratory outcomes in these children including the study of pulmonary function test (PFT) trajectories and incidence of recurrent wheeze/asthma from infancy through early adolescence in offspring of pregnant smokers randomized to vitamin C versus placebo. This will allow the investigators to study the duration of the protection vitamin C provides in the face of in-utero smoke, the relationship between PFTs and the development of recurrent wheeze and/or asthma. In addition we have preliminary data suggesting that, in parallel with the effects of vitamin C on the reduction of pulmonary harm, the supplementary vitamin C blocked the majority of significant changes in DNA methylation induced by maternal smoking in placentas, cord blood and offspring cheek cells. Thus this study will also study the association between the prevention of wheeze/asthma associated with maternal smoking during pregnancy and the prevention of epigenetic changes caused by maternal smoking during pregnancy. By linking the clinical outcomes of decreased wheeze/asthma and pulmonary function in offspring of smokers to epigenetic changes, this study has the potential to identify genes linked to the effects of maternal smoking on lung development and the protective effects of vitamin C.


Recruitment information / eligibility

Status Recruiting
Enrollment 420
Est. completion date December 1, 2024
Est. primary completion date December 1, 2023
Accepts healthy volunteers No
Gender All
Age group 6 Months to 11 Years
Eligibility Inclusion Criteria: - Women and their offspring randomized to vitamin C versus placebo during pregnancy in VCSIP1 or VCSIP2 as well as pregnant nonsmokers and their offspring enrolled as the reference group in VCSIP 1 or VCSIP2 Exclusion Criteria: - Patients specifically withdrawing consent from VCSIP1 or VCSIP2

Study Design


Intervention

Other:
No current intervention
This is a follow-up of two randomized trials. No active intervention is being given in the follow-up

Locations

Country Name City State
United States Indiana University Indianapolis Indiana
United States Oregon Health and Science University Portland Oregon

Sponsors (3)

Lead Sponsor Collaborator
Oregon Health and Science University Indiana University, National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

McEvoy CT, Schilling D, Clay N, Jackson K, Go MD, Spitale P, Bunten C, Leiva M, Gonzales D, Hollister-Smith J, Durand M, Frei B, Buist AS, Peters D, Morris CD, Spindel ER. Vitamin C supplementation for pregnant smoking women and pulmonary function in thei — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Improved pulmonary function The first primary aim of this study is to demonstrate improved pulmonary function trajectories as measured with forced expiratory flows through 15 years of age in the offspring of pregnant smokers randomized to vitamin C (500 mg/day) versus placebo. through 15 years of age
Primary Decreased recurrent wheeze/asthma The second primary aim of this study is to demonstrate a decreased incidence of recurrent wheeze/ asthma through 15 years of age in the offspring of pregnant smokers randomized to vitamin C (500 mg/day) versus placebo. through 15 years of age
Secondary Decreased incidence of recurrent wheeze/asthma A secondary aim of this study is to demonstrate a decreased incidence of recurrent wheeze/asthma through 15 years of age in offspring of pregnant smokers randomized to vitamin C (500 mg/day) versus placebo through 15 years of age
Secondary Epigenetic changes An additional secondary aim of the study is the analysis of epigenetic changes caused by maternal smoking and reversed by vitamin C at birth. DNA methylation will be measured in biologic samples and then followed longitudinally through ages 15. through 15 years of age
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