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

NCT03206710 | Completed DMC

• 2 other identifiers: VCSIP ECHOUG3OD023288
• Study Type: observational
• Target: 395
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

vitamin C; ascorbic acid; wheeze; nicotine; smoke exposure; long term follow up; pulmonary function testing; forced expiratory flows

Outcome Measures

Primary Outcomes (2)

• Improved pulmonary function

  The first primary aim of this study is to demonstrate improved pulmonary function trajectories as measured with forced expiratory flows through 15 years of age in the offspring of pregnant smokers randomized to vitamin C (500 mg/day) versus placebo.

  through 15 years of age

• Decreased recurrent wheeze/asthma

  The second primary aim of this study is to demonstrate a decreased incidence of recurrent wheeze/ asthma through 15 years of age in the offspring of pregnant smokers randomized to vitamin C (500 mg/day) versus placebo.

  through 15 years of age

Secondary Outcomes (2)

• Decreased incidence of recurrent wheeze/asthma

  through 15 years of age

• Epigenetic changes

  through 15 years of age

Study Arms (3)

smokers who received Vitamin C

Other: No current intervention

smokers who received placebo

Other: No current intervention

control group non-smokers

Other: No current intervention

Interventions

No current intervention OTHER

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

control group non-smokers; smokers who received Vitamin C; smokers who received placebo

Eligibility Criteria

• Age: 6 Months - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

This study is a follow-up of women and their offspring who previously participated in NCT00632476 and/or NCT01723696.

You may qualify if:

• 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

You may not qualify if:

• Patients specifically withdrawing consent from VCSIP1 or VCSIP2

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Indiana University: collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (2)

Indiana University

Indianapolis, Indiana, 47405, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Related Publications (1)

• McEvoy CT, Schilling D, Clay N, Jackson K, Go MD, Spitale P, Bunten C, Leiva M, Gonzales D, Hollister-Smith J, Durand M, Frei B, Buist AS, Peters D, Morris CD, Spindel ER. Vitamin C supplementation for pregnant smoking women and pulmonary function in their newborn infants: a randomized clinical trial. JAMA. 2014 May;311(20):2074-82. doi: 10.1001/jama.2014.5217.

  PMID: 24838476 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

buccal swabs, hair, blood, and urine

MeSH Terms

Conditions

Asthma; Respiratory Sounds

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MCR

Study Record Dates

• First Submitted: June 27, 2017
• First Posted: July 2, 2017
• Study Start: June 1, 2017
• Primary Completion: December 1, 2023
• Study Completion: December 31, 2024
• Last Updated: March 21, 2025

Record last verified: 2025-03

Locations

US (2)