Vitamin C Supplementation to Pregnant Smokers: Follow-up of 2 Randomized Trials Plus Changes in DNA Methylation
| Status: | Recruiting |
|---|---|
| Conditions: | Asthma, Asthma, Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | Any - 11 |
| Updated: | 10/19/2018 |
| Start Date: | June 1, 2017 |
| End Date: | December 2024 |
| Contact: | Cindy McEvoy, MD, MCR |
| Email: | mcevoyc@ohsu.edu |
| Phone: | 503-494-0085 |
Maternal Vitamin C Supplementation to Decrease Effects of Smoking During Pregnancy on Infant Lung Function and Health: Follow-up of 2 Randomized Trials and Association With Changes in DNA Methylation
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.
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.
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.
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.
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
We found this trial at
2
sites
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
Portland, Oregon 97239
503 494-8311
Phone: 503-494-0085
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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