Vitamin C to Decrease Effects of Smoking in Pregnancy on Infant Lung Function (VCSIP) Longer Term Follow Up
NCT ID: NCT06106646
Last Updated: 2025-03-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
225 participants
OBSERVATIONAL
2023-10-11
2028-08-31
Brief Summary
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Detailed Description
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The secondary outcomes are:
1. A single low dose high-resolution computed tomography (HRCT) image of the lungs (acquired during inspiration) will be done at 10 years of age in offspring of pregnant smokers who were randomized to vitamin C (500 mg/day) versus placebo during pregnancy. Image analysis will be performed by Dr. Miranda Kirby's Quantitative Image Analysis in Medicine laboratory at Ryerson University in Toronto, ON using certified pulmonary image analysis software. The airway lumen cross sectional areas to at least the fifth generation of airways will be compared between the two groups of children. The number of airways and the lumen, wall, and total cross sectional areas and the segment lengths will also be quantified.
2. A secondary aim is to quantify the differences in DNA methylation between the two groups and measure the correlation between the differences in DNA methylation and respiratory outcomes.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Offspring of smokers who received Vitamin C
In the original VCSIP study, pregnant women were randomized to receive either extra Vitamin C every day (500mg/day) or placebo.
No active intervention in this protocol (previously randomized to Vitamin C)
In the original VCSIP study, pregnant women were randomized to receive either extra Vitamin C every day (500mg/day) or placebo. This trial is a follow-up trial with no active intervention.
Offspring of smokers who received Placebo
In the original VCSIP study, pregnant women were randomized to receive either extra Vitamin C every day (500mg/day) or placebo.
No active intervention in this protocol (previously randomized to Placebo)
In the original VCSIP study, pregnant women were randomized to receive either extra Vitamin C every day (500mg/day) or placebo. This trial is a follow-up trial with no active intervention.
Offspring of non-smokers
No interventions assigned to this group
Interventions
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No active intervention in this protocol (previously randomized to Vitamin C)
In the original VCSIP study, pregnant women were randomized to receive either extra Vitamin C every day (500mg/day) or placebo. This trial is a follow-up trial with no active intervention.
No active intervention in this protocol (previously randomized to Placebo)
In the original VCSIP study, pregnant women were randomized to receive either extra Vitamin C every day (500mg/day) or placebo. This trial is a follow-up trial with no active intervention.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
6 Years
16 Years
ALL
No
Sponsors
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Indiana University
OTHER
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Oregon Health and Science University
OTHER
Responsible Party
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Cynthia McEvoy
Principal Investigator
Principal Investigators
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Cindy McEvoy, MD, MCR
Role: PRINCIPAL_INVESTIGATOR
Oregon Health and Science University
Locations
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Indiana University
Indianapolis, Indiana, United States
Oregon Health and Science University (OHSU)
Portland, Oregon, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
McEvoy CT, Shorey-Kendrick LE, Milner K, Schilling D, Tiller C, Vuylsteke B, Scherman A, Jackson K, Haas DM, Harris J, Park BS, Vu A, Kraemer DF, Gonzales D, Bunten C, Spindel ER, Morris CD, Tepper RS. Vitamin C to pregnant smokers persistently improves infant airway function to 12 months of age: a randomised trial. Eur Respir J. 2020 Dec 3;56(6):1902208. doi: 10.1183/13993003.02208-2019. Print 2020 Dec.
Blue SW, McEvoy CT, Spindel ER, Shorey-Kendrick LE, Davies MH, O'Sullivan SM, Erikson DW. Analysis of nicotine in plasma, brain, and hair samples with the same liquid chromatography-tandem mass spectrometry method. Rapid Commun Mass Spectrom. 2023 Sep 15;37(17):e9613. doi: 10.1002/rcm.9613. No abstract available.
McEvoy CT, Shorey-Kendrick LE, Milner K, Schilling D, Tiller C, Vuylsteke B, Scherman A, Jackson K, Haas DM, Harris J, Schuff R, Park BS, Vu A, Kraemer DF, Mitchell J, Metz J, Gonzales D, Bunten C, Spindel ER, Tepper RS, Morris CD. Oral Vitamin C (500 mg/d) to Pregnant Smokers Improves Infant Airway Function at 3 Months (VCSIP). A Randomized Trial. Am J Respir Crit Care Med. 2019 May 1;199(9):1139-1147. doi: 10.1164/rccm.201805-1011OC.
Shorey-Kendrick LE, McEvoy CT, O'Sullivan SM, Milner K, Vuylsteke B, Tepper RS, Haas DM, Park B, Gao L, Vu A, Morris CD, Spindel ER. Impact of vitamin C supplementation on placental DNA methylation changes related to maternal smoking: association with gene expression and respiratory outcomes. Clin Epigenetics. 2021 Sep 19;13(1):177. doi: 10.1186/s13148-021-01161-y.
Other Identifiers
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VCSIP LTFU
Identifier Type: -
Identifier Source: org_study_id
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