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NCT03206710Completed

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

Maternal Vitamin C Supplementation to Decrease Effects of Smoking During Pregnancy on Infant Lung Function and Health: Follow-up of 2 Randomized Trials and Association With Changes in DNA Methylation

Source: ClinicalTrials.gov · Last updated 21 Mar 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
395 (actual)
First submitted
27 Jun 2017
Start date
1 Jun 2017
Primary completion date
1 Dec 2023
Lead sponsor
Oregon Health and Science University
Diseases
Asthma
NCT number
NCT03206710

What you commit to

  • Study type: Observational
  • Participants enrolled: 395
  • From 1 Jun 2017 to the primary completion date, 1 Dec 2023
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • Patients specifically withdrawing consent from VCSIP1 or VCSIP2

Who the study is looking for

  • Women and their offspring randomized to vitamin C versus placebo during pregnancy in VCSIP1 or VCSIP2 as well as pregnant nonsmokers and their offspring enrolled as the reference group in VCSIP 1 or VCSIP2

Age in the registry: 6 months to 11 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Indiana University
Coordinator of this site? Confirm its status
IndianapolisUnited StatesUnknown status
Oregon Health and Science University
Coordinator of this site? Confirm its status
PortlandUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.