Using vitamin C to improve lung function in children of pregnant smokers
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)
Oregon Health and Science University · NCT06106646
This study is testing if giving pregnant women vitamin C can help improve lung function in their children who were exposed to smoking during pregnancy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 225 (estimated) |
| Ages | 6 Years to 16 Years |
| Sex | All |
| Sponsor | Oregon Health and Science University (other) |
| Locations | 2 sites (Indianapolis, Indiana and 1 other locations) |
| Trial ID | NCT06106646 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the long-term effects of prenatal vitamin C supplementation on the pulmonary function of children born to mothers who smoked during pregnancy. Following up on the original VCSIP trial, the study will compare airway function tests and the occurrence of wheezing in children at 10 years of age, based on whether their mothers received vitamin C or a placebo during pregnancy. The study will also include advanced imaging techniques to analyze lung structure and DNA methylation differences between the two groups.
Who should consider this trial
Good fit: Ideal candidates include children of mothers who participated in the original VCSIP study, specifically those whose mothers smoked during pregnancy.
Not a fit: Patients who were not part of the original VCSIP study or whose mothers did not smoke during pregnancy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved lung health in children exposed to smoking in utero.
How similar studies have performed: Previous studies have shown promising results regarding the benefits of vitamin C supplementation in similar contexts, but this specific long-term follow-up is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women and their offspring randomized to vitamin C versus placebo during pregnancy as well as pregnant nonsmokers and their offspring enrolled as the reference group in the original VCSIP study Exclusion Criteria: * participants who specifically withdraw consent
Where this trial is running
Indianapolis, Indiana and 1 other locations
- Indiana University — Indianapolis, Indiana, United States (RECRUITING)
- Oregon Health and Science University (OHSU) — Portland, Oregon, United States (RECRUITING)
Study contacts
- Principal investigator: Cindy McEvoy, MD, MCR — Oregon Health and Science University
- Study coordinator: Cindy McEvoy, MD, MCR
- Email: mcevoyc@ohsu.edu
- Phone: 503-494-0223
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Asthma, Pulmonary Function, Wheezing, In Utero Nicotine, Pulmonary Function Testing, Wheeze, Vitamin C, Antioxidants