VCSIP Follow-up Study

NCT03203603 | Completed DMC

• 1 other identifier: VCSIP-Renewal
• Study Type: observational
• Target: 242
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Asthma; Pulmonary Function; Wheezing; In Utero Nicotine

Keywords

asthma; pulmonary function testing; wheeze; vitamin C; antioxidants; forced expiratory flows

Outcome Measures

Primary Outcomes (1)

• Improved pulmonary function, spirometry

  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.

  5 years of age

Secondary Outcomes (1)

• Decreased incidence of wheeze

  5 years of age

Study Arms (3)

Offspring of smokers who got vitamin C

Offspring of pregnant smokers randomized to vitamin C during the initial randomized portion of the VCSIP study

Other: No active intervention

Offspring of smokers who got placebo

Offspring of pregnant smokers randomized to placebo during the initial randomized portion of the VCSIP study

Other: No active intervention

Offspring of pregnant non-smokers

Offspring of pregnant non-smokers who were followed in a similar fashion during pregnancy as the randomized pregnant smokers

Other: No active intervention

Interventions

No active intervention OTHER

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

Offspring of pregnant non-smokers; Offspring of smokers who got placebo; Offspring of smokers who got vitamin C

Eligibility Criteria

• Age: 6 Months - 4 Years
• Sex: all
• Age Groups: Child (0-17)
• 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, PeaceHealth Southwest Washington Medical Center in Vancouver, Washington or Indiana University in Indianapolis, Indiana. We are now following the offspring of those pregnant smokers (and control group non-smokers).

You may qualify if:

• 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.

You may not qualify if:

• Patients specifically withdrawing consent.

Sponsors & Collaborators

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

Study Sites (2)

Indiana University

Indianapolis, Indiana, 46202-5167, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Related Publications (4)

• 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 BACKGROUND

• Shorey-Kendrick LE, McEvoy CT, Milner K, Harris J, Brownsberger J, Tepper RS, Park B, Gao L, Vu A, Morris CD, Thompson EE, Ober C, Spindel ER. Vitamin C supplementation to pregnant smokers alters asthma- and allergy-associated CpGs in child buccal DNA at 5 years of age. Clin Epigenetics. 2025 Oct 3;17(1):155. doi: 10.1186/s13148-025-01965-2.

  PMID: 41044653 DERIVED

• Shorey-Kendrick LE, McEvoy CT, Milner K, Harris J, Brownsberger J, Tepper RS, Park B, Gao L, Vu A, Morris CD, Spindel ER. Improvements in lung function following vitamin C supplementation to pregnant smokers are associated with buccal DNA methylation at 5 years of age. Clin Epigenetics. 2024 Feb 27;16(1):35. doi: 10.1186/s13148-024-01644-8.

  PMID: 38413986 DERIVED

• McEvoy CT, Shorey-Kendrick LE, Milner K, Harris J, Vuylsteke B, Cunningham M, Tiller C, Stewart J, Schilling D, Brownsberger J, Titus H, MacDonald KD, Gonzales D, Vu A, Park BS, Spindel ER, Morris CD, Tepper RS. Effect of Vitamin C Supplementation for Pregnant Smokers on Offspring Airway Function and Wheeze at Age 5 Years: Follow-up of a Randomized Clinical Trial. JAMA Pediatr. 2023 Jan 1;177(1):16-24. doi: 10.1001/jamapediatrics.2022.4401.

  PMID: 36409489 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

buccal swabs, hair, blood and urine will be collected.

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 Officials

• Cindy McEvoy, MD, MCR

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

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: March 28, 2017
• First Posted: June 29, 2017
• Study Start: March 27, 2017
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2024
• Last Updated: March 25, 2025

Record last verified: 2025-03

Locations

US (2)