RecruitingNCT06106646

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

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)

Sponsor

Oregon Health and Science University

Enrollment

225 participants

Start Date

Oct 11, 2023

Study Type

OBSERVATIONAL

Conditions

Asthma Pulmonary Function Wheezing In Utero Nicotine

Summary

The overall aims of this protocol are to determine whether prenatal supplementation with vitamin C to pregnant smokers can improve pulmonary function at 10 years of age in their offspring. This is an additional continuation of the Vitamin C to Decrease Effects of Smoking in Pregnancy on Infant Lung Function (VCSIP) trial, to follow the offspring through 10 years of age. The hypothesis for this protocol is an extension of the VCSIP trial that supplemental vitamin C in pregnant smokers can significantly improve their children's airway function tests. The investigators aim to demonstrate sustained improvement in airway/pulmonary function and trajectory through 10 years of age.

Eligibility

Min Age: 6 YearsMax Age: 16 Years

Plain Language Summary

Simplified for easier understanding

This is a long-term follow-up study for children and mothers who participated in the original VCSIP trial, which tested whether vitamin C supplementation during pregnancy in women who smoke could protect infant lung function. This follow-up is tracking how those children's lung health has progressed over time. **You may be eligible if...** - You and/or your child were enrolled in the original VCSIP study (either in the vitamin C group, placebo group, or as a non-smoking reference group) **You may NOT be eligible if...** - You or your child have specifically withdrawn consent from the original study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTNo active intervention in this protocol (previously randomized to Vitamin C)

In the original VCSIP study, pregnant women were randomized to receive either extra Vitamin C every day (500mg/day) or placebo. This trial is a follow-up trial with no active intervention.

OTHERNo active intervention in this protocol (previously randomized to Placebo)

In the original VCSIP study, pregnant women were randomized to receive either extra Vitamin C every day (500mg/day) or placebo. This trial is a follow-up trial with no active intervention.

Locations(2)

Indiana University

Indianapolis, Indiana, United States

Oregon Health and Science University (OHSU)

Portland, Oregon, United States

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NCT06106646

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