Vitamin C for Infant Lung Function
(VCSIP Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether taking vitamin C during pregnancy can improve lung function in children born to mothers who smoked while pregnant. Researchers are monitoring these children to determine if the benefits persist until age 10. They are comparing three groups: children whose mothers smoked and took vitamin C, children whose mothers smoked and took a placebo, and children whose mothers did not smoke. Women who participated in the original study and their children are eligible for this follow-up.
As a Phase 2 trial, this research measures how well vitamin C improves lung function in an initial, smaller group of children, offering participants a chance to contribute to important findings.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that taking vitamin C during pregnancy is safe for women who smoke. In studies where pregnant women took 500 mg of vitamin C daily, it was well-tolerated and did not cause any problems. There is no strong evidence of harmful side effects for the mothers or their babies.
These studies also found that vitamin C can improve lung function in newborns. Specifically, babies born to mothers who took vitamin C performed better on breathing tests.
Overall, taking vitamin C appears to be a safe choice for pregnant smokers, with research supporting its benefits for the baby's lung health.12345Why are researchers excited about this trial?
Researchers are excited about using Vitamin C to help improve infant lung function because it offers a unique approach compared to standard care for managing the effects of smoking during pregnancy. Most current strategies focus on smoking cessation and managing complications after birth. However, Vitamin C could directly enhance lung development by combating oxidative stress caused by smoking in pregnant women. This simple, inexpensive supplement may provide a proactive solution to protect infant lung health before any damage occurs.
What evidence suggests that this trial's treatments could be effective for improving lung function in children of pregnant smokers?
This trial will compare the offspring of smokers who received Vitamin C during pregnancy with those who received a placebo, as well as with offspring of non-smokers. Research has shown that taking vitamin C during pregnancy can improve lung function in babies born to mothers who smoke. One study found that extra vitamin C helped newborns breathe more easily and reduced wheezing in their first year. Another study suggested that children might have fewer cases of asthma up to age ten if their mothers took vitamin C while pregnant. Additionally, vitamin C has improved certain aspects of lung function, such as the amount of air a person can exhale forcefully. These findings suggest that vitamin C could provide long-term breathing benefits for children of mothers who smoke.16789
Who Is on the Research Team?
Cindy McEvoy, MD, MCR
Principal Investigator
Oregon Health and Science University
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Pregnant smokers receive daily supplementation of Vitamin C (500 mg/day) or placebo
Follow-up
Participants are monitored for pulmonary function and respiratory outcomes through 10 years of age
Long-term assessment
Assessment of airway lumen cross sectional areas and DNA methylation differences at 10 years of age
What Are the Treatments Tested in This Trial?
Interventions
- Vitamin C
Find a Clinic Near You
Who Is Running the Clinical Trial?
Oregon Health and Science University
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Indiana University
Collaborator