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Offspring of non-smokers for Pulmonary Function Tests (VCSIP Trial)

N/A
Recruiting
Led By Cindy McEvoy, MD, MCR
Research Sponsored by Oregon Health and Science University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 years of age
Awards & highlights

VCSIP Trial 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.

Eligible Conditions
  • Pulmonary Function Tests
  • Fetal Nicotine Syndrome
  • Asthma
  • Wheezing

VCSIP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

VCSIP Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 years of age
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 years of age for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Sustained improvement in pulmonary function and trajectory
Secondary outcome measures
Airway lumen cross sectional areas
Changes in DNA methylation
Occurrence of wheeze

VCSIP Trial Design

3Treatment groups
Experimental Treatment
Group I: Offspring of smokers who received Vitamin CExperimental Treatment1 Intervention
In the original VCSIP study, pregnant women were randomized to receive either extra Vitamin C every day (500mg/day) or placebo.
Group II: Offspring of smokers who received PlaceboExperimental Treatment1 Intervention
In the original VCSIP study, pregnant women were randomized to receive either extra Vitamin C every day (500mg/day) or placebo.
Group III: Offspring of non-smokersExperimental Treatment0 Interventions

Find a Location

Who is running the clinical trial?

Oregon Health and Science UniversityLead Sponsor
973 Previous Clinical Trials
6,845,804 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,835 Previous Clinical Trials
47,310,417 Total Patients Enrolled
Indiana UniversityOTHER
980 Previous Clinical Trials
982,757 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
JamaJournal
Vitamin C Supplementation for Pregnant Smoking Women and Pulmonary Function in Their Newborn Infants
McEvoy, Cindy T., Diane Schilling, Nakia Clay, Keith Jackson, Mitzi D. Go, Patricia Spitale, Carol Bunten, et al.. 2014. “Vitamin C Supplementation for Pregnant Smoking Women and Pulmonary Function in Their Newborn Infants”. Jama. American Medical Association (AMA). doi:10.1001/jama.2014.5217.
clinicaltrials.govStudy
Vitamin C to Decrease Effects of Smoking in Pregnancy on Infant Lung Function (VCSIP) Longer Term Follow Up
Cynthia McEvoy 2023. "Vitamin C to Decrease Effects of Smoking in Pregnancy on Infant Lung Function (VCSIP) Longer Term Follow Up". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06106646.
All > Vancouver
~150 spots leftby Aug 2027
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