AsthmaVCSIPRenewalNCT03203603
VCSIP Follow-up Study
An observational study of Asthma and Pulmonary Function, run by Oregon Health and Science University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 4 years
- Conditions the study is for
- Asthma, Pulmonary Function, Wheezing
- What is being tested?
- No active intervention
- How many people
- 242 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Mar 2017to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 4 years
- All sexes
- Child
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).
Who may be able to join
- 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.
Who cannot join
- Patients specifically withdrawing consent.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Indiana University
Indianapolis, Indiana, 46202-5167
Oregon Health and Science University
Portland, Oregon, 97239
About this study
Official title: Vitamin C to Decrease the Effects of Smoking in Pregnancy on Infant Lung Function (VCSIP): Follow-up of a Randomized Trial
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.
Read the detailed description
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. The reasons for this protocol are to follow the children born to mothers randomized in the VCSIP to the age of 5 to differentiate the patients with transient versus recurrent wheeze (and therefore more likely to develop asthma); to determine if early protective effects of vitamin C are sustained to this older age; and to continue to collect biologic samples from the children for future mechanistic studies of vitamin C action.
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. The investigators hypothesize that vitamin C supplementation in pregnancy will block the adverse effects of maternal smoking on offspring pulmonary function measured at 5 years of age by spirometry. Impulse oscillometry (IOS) will also be used at 3-5 years of age to assess pulmonary function.
Specific Aim 2 (Secondary Outcome): The secondary aim of this study is to demonstrate a decreased incidence of wheeze at 5 years of age in offspring of pregnant smokers randomized to vitamin C (500 mg/day) versus placebo. The investigators hypothesize that vitamin C supplementation during pregnancy will decrease the incidence of wheeze at 5 years of age in offspring of smokers. Respiratory health will be assessed by quarterly validated respiratory questionnaires and clinician report.
- Conditions
- Asthma, Pulmonary Function, Wheezing, In Utero Nicotine
- Being tested
- No active intervention
- Keywords
- asthma, pulmonary function testing, wheeze, vitamin C, antioxidants, forced expiratory flows
- Medical subject headings
- Asthma, Respiratory Sounds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No active interventionOther
This is a follow-up of a randomized trial. No active intervention is being given in the follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Offspring of smokers who got vitamin C | Offspring of pregnant smokers randomized to vitamin C during the initial randomized portion of the VCSIP study Receives: 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 Receives: 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 Receives: Other: No active intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years of age
Secondary outcomes (1)
Decreased incidence of wheeze
The secondary aim of this study is to demonstrate a decreased incidence of wheeze at 5 year of age in offspring of pregnant smokers randomized to vitamin C (500 mg/day) versus placebo
Measured: 5 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2017
- Study start27 Mar 2017
- Primary completion31 Dec 2021
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- Indiana University, National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Cynthia McEvoy, Oregon Health and Science University
- Investigators
- Cindy McEvoy, MD, MCR, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03203603
- Sponsor's protocol ID
- VCSIP-Renewal
- Acronym
- VCSIPRenewal
- Status last verified
- Mar 2025
- First submitted
- 28 Mar 2017
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 24838476Shorey-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.
PubMed 41044653Shorey-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.
PubMed 38413986McEvoy 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.
PubMed 36409489
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin C to Decrease the Effects of Smoking in Pregnancy on Infant Lung Function (VCSIP): Follow-up of a Randomized Trial
- ClinicalTrials.gov ID
- NCT03203603
- Acronym / sponsor ID
- VCSIPRenewal / VCSIP-Renewal
- Conditions
- Asthma, Pulmonary Function, Wheezing, In Utero Nicotine
- Keywords
- asthma, pulmonary function testing, wheeze, vitamin C, antioxidants, forced expiratory flows
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- Indiana University, National Institutes of Health (NIH)
- Study start
- 27 Mar 2017 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 29 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. The reasons for this protocol are to follow the children born to mothers randomized in the VCSIP to the age of 5 to differentiate the patients with transient versus recurrent wheeze (and therefore more likely to develop asthma); to determine if early protective effects of vitamin C are sustained to this older age; and to continue to collect biologic samples from the children for future mechanistic studies of vitamin C action.
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. The investigators hypothesize that vitamin C supplementation in pregnancy will block the adverse effects of maternal smoking on offspring pulmonary function measured at 5 years of age by spirometry. Impulse oscillometry (IOS) will also be used at 3-5 years of age to assess pulmonary function.
Specific Aim 2 (Secondary Outcome): The secondary aim of this study is to demonstrate a decreased incidence of wheeze at 5 years of age in offspring of pregnant smokers randomized to vitamin C (500 mg/day) versus placebo. The investigators hypothesize that vitamin C supplementation during pregnancy will decrease the incidence of wheeze at 5 years of age in offspring of smokers. Respiratory health will be assessed by quarterly validated respiratory questionnaires and clinician report.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Offspring of smokers who got vitamin C | – | Other: No active interventionOffspring of pregnant smokers randomized to vitamin C during the initial randomized portion of the VCSIP study |
| Offspring of smokers who got placebo | – | Other: No active interventionOffspring of pregnant smokers randomized to placebo during the initial randomized portion of the VCSIP study |
| Offspring of pregnant non-smokers | – | Other: No active interventionOffspring of pregnant non-smokers who were followed in a similar fashion during pregnancy as the randomized pregnant smokers |
Who may qualify
- Ages
- 6 months to 4 years
- Sex
- All
- Age groups
- Child
- 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).
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients specifically withdrawing consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No active interventionThis is a follow-up of a randomized trial. No active intervention is being given in the follow-up. | Other | Offspring of pregnant non-smokers, Offspring of smokers who got placebo, Offspring of smokers who got vitamin C |
Primary outcome
Improved pulmonary function, spirometry
Time frame: 5 years of age
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.
1 secondary outcome
Decreased incidence of wheeze
Time frame: 5 years of age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Background: PubMed 24838476McEvoy 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.
- Derived from this study: PubMed 41044653Shorey-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.
- Derived from this study: PubMed 38413986Shorey-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.
- Derived from this study: PubMed 36409489McEvoy 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cindy McEvoy, MD, MCR principal investigator
Oregon Health and Science University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Pulmonary Function, run by Oregon Health and Science University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improved pulmonary function, spirometry (time frame: 5 years of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03203603, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025.