RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Quick Facts

Study Start:2023-10-11
Study Completion:2028-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06106646

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Years to 16 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * 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
  1. * participants who specifically withdraw consent

Contacts and Locations

Study Contact

Cindy McEvoy, MD, MCR
CONTACT
503-494-0223
mcevoyc@ohsu.edu
Kristin Milner, BS, CMA, CCRP
CONTACT
503-494-0223
milner@ohsu.edu

Principal Investigator

Cindy McEvoy, MD, MCR
PRINCIPAL_INVESTIGATOR
Oregon Health and Science University

Study Locations (Sites)

Indiana University
Indianapolis, Indiana, 46902
United States
Oregon Health and Science University (OHSU)
Portland, Oregon, 97217
United States

Collaborators and Investigators

Sponsor: Oregon Health and Science University

  • Cindy McEvoy, MD, MCR, PRINCIPAL_INVESTIGATOR, Oregon Health and Science University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-11
Study Completion Date2028-08

Study Record Updates

Study Start Date2023-10-11
Study Completion Date2028-08

Terms related to this study

Keywords Provided by Researchers

  • Asthma
  • Pulmonary Function
  • Pulmonary Function Testing
  • Wheeze
  • Vitamin C
  • Antioxidants
  • Forced Expiratory Flows
  • Spirometry
  • Lung Function
  • Epigenetics
  • High resolution CT scans

Additional Relevant MeSH Terms

  • Asthma
  • Pulmonary Function
  • Wheezing
  • In Utero Nicotine