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

NCT06106646 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 225

Last updated 2025-03-18

No results posted yet for this study

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.

Conditions

  • Asthma
  • Pulmonary Function
  • Wheezing
  • In Utero Nicotine

Interventions

DIETARY_SUPPLEMENT

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.

OTHER

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.

Sponsors & Collaborators

  • Indiana University

    collaborator OTHER

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Oregon Health and Science University

    lead OTHER

Principal Investigators

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

Eligibility

Min Age
6 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-11
Primary Completion
2027-08-31
Completion
2028-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06106646 on ClinicalTrials.gov