Recruiting

Vitamin C

Sponsor:

Oregon Health and Science University

Code:

NCT06106646

Conditions

Asthma

Pulmonary Function

Wheezing

In Utero Nicotine

Eligibility Criteria

Sex: All

Age: 6 - 16

Healthy Volunteers: Not accepted

Interventions

No active intervention in this protocol (previously randomized to Vitamin C)

No active intervention in this protocol (previously randomized to Placebo)

Study Details

Brief 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

Study ID

NCT06106646

Start date

Oct 11, 2023

Status verified date

Mar, 2025

Completion date

Aug, 2028

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 16

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • participants who specifically withdraw consent

Study Design

Enrollment

225 participants

Anticipated

Interventions and Outcome Measures

Arms

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

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.

Primary outcome measure

  • Sustained improvement in pulmonary function and trajectory [ Time Frame: 10 years of age ]

Central Contacts and Locations

Central contacts

Cindy McEvoy, MD, MCR

503-494-0223mcevoyc@ohsu.edu

Kristin Milner, BS, CMA, CCRP

503-494-0223milner@ohsu.edu

Locations

Indiana University

Recruiting

Indianapolis, Indiana, United States, 46902

Contacts

Christina Tiller

ctiller@iu.edu

Principal Investigator:

Robert Tepper, MD

Oregon Health and Science University (OHSU)

Recruiting

Portland, Oregon, United States, 97217

Contacts

Kristin Milner

971-404-0223milner@ohsu.edu

Principal Investigator:

Cindy McEvoy, MD

More Information

Sponsor

Oregon Health and Science University

Last update posted

Mar 18, 2025

Last verified

Mar, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Oregon Health and Science University on 2025-03-18.