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Completed

NCT Number: NCT03203603

VCSIP Follow-up Study

The overall aims of this protocol are to determine whether prenatal supplementation with vitamin C to pregnant smokers can improve pulmonary function and decrease wheeze at 5 years of age in their offspring. This is a continuation of the VCSIP trial, to follow the offspring through 5 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 PFTs and decrease the incidence of wheeze.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases In Utero Nicotine Lung Diseases Lung Diseases, Obstructive Pathological Conditions, Signs and Symptoms Pulmonary Function Respiratory Hypersensitivity Respiratory Sounds Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Wheezing

Age range

6 month–4 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Indiana University, Indianapolis, Indiana, United States

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About this study

The overall aims of this protocol are to determine whether prenatal supplementation with vitamin C to pregnant smokers can improve pulmonary function and decrease wheeze at 5 years of age in their offspring. This is a continuation of the VCSIP trial, to follow the offspring through 5 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 PFTs and decrease the incidence of wheeze. The reasons for this protocol are to follow the children born to mothers randomized in the VCSIP to the age of 5 to differentiate the patients with transient versus recurrent wheeze (and therefore more likely to develop asthma); to determine if early protective effects of vitamin C are sustained to this older age; and to continue to collect biologic samples from the children for future mechanistic studies of vitamin C action.

The primary aim of this study is to demonstrate improved pulmonary function at 5 years of age in the offspring of pregnant smokers randomized to vitamin C (500 mg/day) versus placebo. The investigators hypothesize that vitamin C supplementation in pregnancy will block the adverse effects of maternal smoking on offspring pulmonary function measured at 5 years of age by spirometry. Impulse oscillometry (IOS) will also be used at 3-5 years of age to assess pulmonary function.

Specific Aim 2 (Secondary Outcome): The secondary aim of this study is to demonstrate a decreased incidence of wheeze at 5 years of age in offspring of pregnant smokers randomized to vitamin C (500 mg/day) versus placebo. The investigators hypothesize that vitamin C supplementation during pregnancy will decrease the incidence of wheeze at 5 years of age in offspring of smokers. Respiratory health will be assessed by quarterly validated respiratory questionnaires and clinician report.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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 current RCT.

Exclusion criteria

  • Patients specifically withdrawing consent.

Treatment and study plan

No active intervention

Other

This is a follow-up of a randomized trial. No active intervention is being given in the follow-up.

Primary outcomes

  1. Improved pulmonary function, spirometry

    Time frame: 5 years of age

    The primary aim of this study is to demonstrate improved pulmonary function at 5 years of age in the offspring of pregnant smokers randomized to vitamin C 500 mg/day versus placebo.

Secondary outcomes

  1. Decreased incidence of wheeze

    Time frame: 5 years of age

    The secondary aim of this study is to demonstrate a decreased incidence of wheeze at 5 year of age in offspring of pregnant smokers randomized to vitamin C (500 mg/day) versus placebo

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • Indiana University
  • National Institutes of Health (NIH)

Registry information

Official study title

Vitamin C to Decrease the Effects of Smoking in Pregnancy on Infant Lung Function (VCSIP): Follow-up of a Randomized Trial

Acronym: VCSIPRenewal

Important dates

Study start
2017
Primary completion
2021
Study completion
2024
First posted
Jun 29, 2017
Registry last updated
Mar 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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