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Vitamin C Supplementation to Pregnant Smokers: Follow-up of 2 Randomized Trials Plus Changes in DNA Methylation (VCSIP-ECHO)

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ClinicalTrials.gov Identifier: NCT03206710
Recruitment Status : Recruiting
First Posted : July 2, 2017
Last Update Posted : July 6, 2017
Sponsor:
Collaborators:
Indiana University
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Cynthia McEvoy, Oregon Health and Science University

Brief 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.

Condition or disease Intervention/treatment
Asthma Wheezing In Utero Nicotine Pulmonary Function Other: No current intervention

Detailed 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.


Study Type : Observational
Estimated Enrollment : 420 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: 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
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Vitamin C

Group/Cohort Intervention/treatment
smokers who received Vitamin C Other: No current intervention
This is a follow-up of two randomized trials. No active intervention is being given in the follow-up

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

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




Primary Outcome Measures :
  1. Improved pulmonary function [ Time Frame: through 15 years of age ]
    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.

  2. Decreased recurrent wheeze/asthma [ Time Frame: through 15 years of age ]
    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.


Secondary Outcome Measures :
  1. Decreased incidence of recurrent wheeze/asthma [ Time Frame: through 15 years of age ]
    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

  2. Epigenetic changes [ Time Frame: through 15 years of age ]
    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.


Biospecimen Retention:   Samples With DNA
buccal swabs, hair, blood, and urine


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Ages Eligible for Study:   6 Months to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
This study is a follow-up of women and their offspring who previously participated in NCT00632476 and/or NCT01723696.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03206710


Contacts
Contact: Cindy McEvoy, MD, MCR 503-494-0085 mcevoyc@ohsu.edu
Contact: Kristin Milner, BA, CMA 971-404-8667 milner@ohsu.edu

Locations
United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 47405
Contact: Rob Tepper, MD       rtepper@iu.ed   
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Cindy McEvoy, MD, MCR    503-494-0085    mcevoyc@ohsu.edu   
Contact: Kristin Milner, BA, CMA    971-404-8667    milner@ohsu.edu   
Sponsors and Collaborators
Oregon Health and Science University
Indiana University
National Institutes of Health (NIH)

Publications of Results:
Responsible Party: Cynthia McEvoy, MD, MCR, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT03206710     History of Changes
Other Study ID Numbers: VCSIP ECHO
UG3OD023288 ( U.S. NIH Grant/Contract )
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: July 6, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Cynthia McEvoy, Oregon Health and Science University:
vitamin C
ascorbic acid
wheeze
nicotine
smoke exposure
long term follow up
pulmonary function testing
forced expiratory flows

Additional relevant MeSH terms:
Respiratory Sounds
Signs and Symptoms, Respiratory
Signs and Symptoms
Vitamins
Ascorbic Acid
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents