Vitamin C to Decrease Effects of Smoking in Pregnancy on Infant Lung Function (VCSIP) Longer Term… (NCT06106646) | Clinical Trial Compass
RecruitingNot Applicable
Vitamin C to Decrease Effects of Smoking in Pregnancy on Infant Lung Function (VCSIP) Longer Term Follow Up
United States225 participantsStarted 2023-10-11
Plain-language summary
The overall aims of this protocol are to determine whether prenatal supplementation with vitamin C to pregnant smokers can improve pulmonary function at 10 years of age in their offspring. This is an additional continuation of the Vitamin C to Decrease Effects of Smoking in Pregnancy on Infant Lung Function (VCSIP) trial, to follow the offspring through 10 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 airway function tests. The investigators aim to demonstrate sustained improvement in airway/pulmonary function and trajectory through 10 years of age.
Who can participate
Age range
6 Years – 16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 original VCSIP study
Exclusion Criteria:
* participants who specifically withdraw consent
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is following children whose mothers smoked during pregnancy to see if vitamin C given during pregnancy has lasting effects on lung function — if my child was exposed to nicotine in the womb, could this follow-up study be worth discussing as a way to track their lung health over time?
2Since this is a longer-term follow-up study rather than a treatment trial, what would actually happen to my child during participation — are there tests, visits, or procedures I should understand before deciding if this fits our family's schedule?
3The study is measuring whether improvements in pulmonary function are sustained over time — does my child's current lung function or any history of wheezing or asthma make them a particularly relevant candidate to discuss with you?
4Because this trial is listed as phase 'not applicable,' it's more of an observational follow-up than a drug trial — does that change the risk profile compared to a standard intervention study, and are there any risks at all my child might be exposed to?
5Even if this study isn't the right fit, is there anything being learned from vitamin C supplementation in smoking pregnancies that might already influence how you would monitor or manage my child's respiratory health going forward?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Sustained improvement in pulmonary function and trajectory