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Vitamin C Supplementation to Pregnant Smokers: Follow-up of 2 Randomized Trials Plus Changes in DNA Methylation

NCT03206710 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 395

Last updated 2025-03-21

No results posted yet for this study

Summary

In a randomized clinical trial (RCT) published in JAMA, the investigators have provided evidence that vitamin C supplementation (500 mg daily during pregnancy) ameliorates the effects of maternal smoking during pregnancy on offspring lung function and subsequent incidence of wheeze by 48% through 1 year of age. The investigators are currently completing a second RCT of vitamin C supplementation in pregnant smokers with more robust measures of pulmonary outcomes. The purpose of this ECHO application is to combine these 2 focused, interventional cohorts to allow critical longitudinal follow-up of respiratory outcomes in these children including the study of pulmonary function test (PFT) trajectories and incidence of recurrent wheeze/asthma from infancy through early adolescence in offspring of pregnant smokers randomized to vitamin C versus placebo.

Conditions

  • Asthma
  • Wheezing
  • In Utero Nicotine
  • Pulmonary Function

Interventions

OTHER

No current intervention

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

Sponsors & Collaborators

  • Indiana University

    collaborator OTHER

  • National Institutes of Health (NIH)

    collaborator NIH

  • Oregon Health and Science University

    lead OTHER

Eligibility

Min Age
6 Months
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-01
Primary Completion
2023-12-01
Completion
2024-12-31

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 NCT03206710 on ClinicalTrials.gov