Actively Recruiting

Age: 6Years - 16Years
All Genders
ID06106646

Assessing the Effect of Vitamin C on Infant Lung Function When Given to Pregnant Women Who Smoke - Long Term Follow-Up of a Randomized Trial

Led by Oregon Health and Science University · Updated on 2025-03-18

225

Participants Needed

2

Research Sites

52 weeks

Total Duration

On this page

Sponsors

O

Oregon Health and Science University

Lead Sponsor

I

Indiana University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are following up on a previous trial that studied whether taking vitamin C during pregnancy can improve lung function in children born to mothers who smoked. This long-term study evaluates airway and pulmonary function in these children up to 10 years of age. The main goal is to see if vitamin C supplementation during pregnancy leads to lasting benefits in children's airway health compared to a placebo group. The original trial involved pregnant women who were randomly assigned to receive either 500 mg of vitamin C daily or a placebo during pregnancy. This follow-up study does not include any new treatments but continues to monitor the children as they grow. Yearly lung function tests using spirometry will measure airway flow, and respiratory questionnaires will track wheezing incidents. Additionally, a low-dose high-resolution lung CT scan will be performed at age 10 to analyze airway structure differences, and DNA methylation changes will be compared between groups. Participants will undergo annual pulmonary function tests through forced expiratory maneuvers until they reach 10 years old. Wheezing occurrences will be recorded using standardized questionnaires every three months. At 10 years, a specialized lung imaging scan will be done to assess airway anatomy. Researchers will analyze lung function trajectories, airway measurements, and epigenetic markers to understand the long-term impact of prenatal vitamin C supplementation on lung health. The study is expected to continue until August 2028.

CONDITIONS

Brief Title

Vitamin C to Decrease Effects of Smoking in Pregnancy on Infant Lung Function (VCSIP) Longer Term Follow Up

Who Can Participate

Age: 6Years - 16Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Women and their children who were randomized to receive vitamin C or placebo during pregnancy in the original VCSIP study
  • Pregnant nonsmokers and their children enrolled as a reference group in the original VCSIP study
Not Eligible

You will not qualify if you...

  • Participants who have specifically withdrawn consent from the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 10 years

Participants' children undergo yearly airway function tests and complete quarterly respiratory questionnaires to monitor lung function and occurrence of wheeze through 10 years of age.

Yearly visits and quarterly questionnaires

Diagnostic Evaluation

Duration - Single timepoint at 10 years

At 10 years of age, participants' children receive a single low dose high-resolution CT scan of the lungs to assess airway structure.

1 visit (in-person)

Trial Site Locations

Total: 2 locations

1

Indiana University

Indianapolis, Indiana, United States, 46902

Actively Recruiting

2

Oregon Health and Science University (OHSU)

Portland, Oregon, United States, 97217

Actively Recruiting

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Research Team

C

Cindy McEvoy, MD, MCR

K

Kristin Milner, BS, CMA, CCRP

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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Published Research Related To This Trial

Vitamin C supplementation for pregnant smoking women and pulmonary function in their newborn infants: a randomized clinical trial.

Cindy T McEvoy, Diane Schilling, Nakia Clay...

https://pubmed.ncbi.nlm.nih.gov/24838476

Effect of Vitamin C Supplementation for Pregnant Smokers on Offspring Airway Function and Wheeze at Age 5 Years: Follow-up of a Randomized Clinical Trial.

Cindy T McEvoy, Lyndsey E Shorey-Kendrick, Kristin Milner...

https://pubmed.ncbi.nlm.nih.gov/36409489

Vitamin C to pregnant smokers persistently improves infant airway function to 12 months of age: a randomised trial.

Cindy T McEvoy, Lyndsey E Shorey-Kendrick, Kristin Milner...

https://pubmed.ncbi.nlm.nih.gov/32616589

Analysis of nicotine in plasma, brain, and hair samples with the same liquid chromatography-tandem mass spectrometry method.

Steven W Blue, Cindy T McEvoy, Eliot R Spindel...

https://pubmed.ncbi.nlm.nih.gov/37580504

Oral Vitamin C (500 mg/d) to Pregnant Smokers Improves Infant Airway Function at 3 Months (VCSIP). A Randomized Trial.

Cindy T McEvoy, Lyndsey E Shorey-Kendrick, Kristin Milner...

https://pubmed.ncbi.nlm.nih.gov/30522343

Impact of vitamin C supplementation on placental DNA methylation changes related to maternal smoking: association with gene expression and respiratory outcomes.

Lyndsey E Shorey-Kendrick, Cindy T McEvoy, Shannon M O'Sullivan...

https://pubmed.ncbi.nlm.nih.gov/34538263