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)

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other, Dietary supplement
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 16
Healthy Volunteers: f
View:

• 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

Locations
United States
Indiana
Indiana University
RECRUITING
Indianapolis
Oregon
Oregon Health and Science University (OHSU)
RECRUITING
Portland
Contact Information
Primary
Cindy McEvoy, MD, MCR
mcevoyc@ohsu.edu
503-494-0223
Backup
Kristin Milner, BS, CMA, CCRP
milner@ohsu.edu
503-494-0223
Time Frame
Start Date: 2023-10-11
Estimated Completion Date: 2028-08
Participants
Target number of participants: 225
Treatments
Offspring of smokers who received Vitamin C
In the original VCSIP study, pregnant women were randomized to receive either extra Vitamin C every day (500mg/day) or placebo.
Offspring of smokers who received Placebo
In the original VCSIP study, pregnant women were randomized to receive either extra Vitamin C every day (500mg/day) or placebo.
Offspring of non-smokers
Related Therapeutic Areas
Sponsors
Collaborators: Indiana University, National Heart, Lung, and Blood Institute (NHLBI)
Leads: Oregon Health and Science University

This content was sourced from clinicaltrials.gov