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

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

Inclusion Criteria1

  • 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 Criteria1

  • participants who specifically withdraw consent

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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