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

November 17, 2023 updated by: Cynthia McEvoy, Oregon Health and Science University

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The primary outcome of this longitudinal follow-up study is the comparison of airway function tests (specifically the forced expiratory flow between 25%and 75% of expired volume [FEF25-75]) measured yearly through 10 years of age by forced expiratory maneuvers with spirometry between the children of the pregnant smokers randomized to vitamin C (500 mg/day) versus placebo during pregnancy. The occurrence of wheeze obtained with quarterly standardized respiratory questionnaires will also be compared between the two groups of children. This is a follow-up of the original "Vitamin C to Decrease Effects of Smoking in Pregnancy on Infant Lung Function" (VCSIP) trial.

The secondary outcomes are:

  1. A single low dose high-resolution computed tomography (HRCT) image of the lungs (acquired during inspiration) will be done at 10 years of age in offspring of pregnant smokers who were randomized to vitamin C (500 mg/day) versus placebo during pregnancy. Image analysis will be performed by Dr. Miranda Kirby's Quantitative Image Analysis in Medicine laboratory at Ryerson University in Toronto, ON using certified pulmonary image analysis software. The airway lumen cross sectional areas to at least the fifth generation of airways will be compared between the two groups of children. The number of airways and the lumen, wall, and total cross sectional areas and the segment lengths will also be quantified.
  2. A secondary aim is to quantify the differences in DNA methylation between the two groups and measure the correlation between the differences in DNA methylation and respiratory outcomes.

Study Type

Observational

Enrollment (Estimated)

225

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Cindy McEvoy, MD, MCR
  • Phone Number: 503-494-0223
  • Email: mcevoyc@ohsu.edu

Study Contact Backup

  • Name: Kristin Milner, BS, CMA, CCRP
  • Phone Number: 503-494-0223
  • Email: milner@ohsu.edu

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46902
        • Recruiting
        • Indiana University
        • Contact:
        • Principal Investigator:
          • Robert Tepper, MD
    • Oregon
      • Portland, Oregon, United States, 97217
        • Recruiting
        • Oregon Health and Science University (OHSU)
        • Contact:
        • Principal Investigator:
          • Cindy McEvoy, MD

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.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

This is a follow up of NCT01723696. In that study, pregnant smokers were recruited at obstetric clinics delivering at OHSU in Portland OR, PeaceHealth Southwest Washington Medical Center in Vancouver, Washington or Indiana University in Indianapolis, Indiana. We are continuing to follow the offspring of those pregnant smokers (and control group non-smokers).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.
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.
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.
Offspring of non-smokers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sustained improvement in pulmonary function and trajectory
Time Frame: 10 years of age
The primary outcome of this longitudinal follow-up study is the comparison of airway function tests (specifically FEF25-75 in liters/sec) measured yearly through 10 years of age by forced expiratory maneuvers with spirometry between the children of the pregnant smokers randomized to vitamin C (500 mg/day) versus placebo during pregnancy. This is a follow-up of the original "Vitamin C to Decrease Effects of Smoking in Pregnancy on Infant Lung Function" (VCSIP) trial.
10 years of age

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of wheeze
Time Frame: 10 years of age
The occurrence of wheeze obtained with quarterly standardized respiratory questionnaires will also be compared between the children of the pregnant smokers randomized to vitamin C (500 mg/day) versus placebo during pregnancy. This is a follow-up of the original "Vitamin C to Decrease Effects of Smoking in Pregnancy on Infant Lung Function" (VCSIP) trial.
10 years of age
Airway lumen cross sectional areas
Time Frame: 10 years of age
A single low dose high-resolution computed tomography (HRCT) image of the lungs (acquired during inspiration) will be done at 10 years of age in offspring of pregnant smokers who were randomized to vitamin C (500 mg/day) versus placebo during pregnancy. Image analysis will be performed by Dr. Miranda Kirby's Quantitative Image Analysis in Medicine laboratory at Ryerson University in Toronto, ON using certified pulmonary image analysis software. The airway lumen cross sectional areas (in mm squared) to at least the fifth generation of airways will be compared between the two groups of children.
10 years of age
Changes in DNA methylation
Time Frame: 10 years of age
A secondary aim is to quantify the differences in DNA methylation between the two groups and measure the correlation between the differences in DNA methylation and respiratory outcomes.
10 years of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Health and Science University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)
Indiana University

Investigators

  • Principal Investigator: Cindy McEvoy, MD, MCR, Oregon Health and Science University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

October 11, 2023

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2028

Study Registration Dates

First Submitted

October 9, 2023

First Submitted That Met QC Criteria

October 27, 2023

First Posted (Actual)

October 30, 2023

Study Record Updates

Last Update Posted (Estimated)

November 21, 2023

Last Update Submitted That Met QC Criteria

November 17, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VCSIP LTFU
  • R01HL162951 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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