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/24838476Actively Recruiting
Led by Oregon Health and Science University · Updated on 2025-03-18
225
Participants Needed
2
Research Sites
52 weeks
Total Duration
O
Oregon Health and Science University
Lead Sponsor
I
Indiana University
Collaborating Sponsor
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
Vitamin C to Decrease Effects of Smoking in Pregnancy on Infant Lung Function (VCSIP) Longer Term Follow Up
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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)
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
C
Cindy McEvoy, MD, MCR
K
Kristin Milner, BS, CMA, CCRP
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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