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Vitamin C to Decrease Effects of Smoking in Pregnancy on Infant Lung Function (VCSIP) Longer Term Follow Up
Sponsor: Oregon Health and Science University
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.
Official title: 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)
Key Details
Gender
All
Age Range
6 Years - 16 Years
Study Type
OBSERVATIONAL
Enrollment
225
Start Date
2023-10-11
Completion Date
2028-08
Last Updated
2025-03-18
Healthy Volunteers
No
Interventions
No 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.
No 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