Vitamin C to Decrease Effects of Smoking in Pregnancy on Infant Lung Function (VCSIP) Longer Term Follow Up
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-16
SponsorOregon Health and Science University
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
participants who specifically withdraw consent
Trial design
Treatments tested in this trial
- No active intervention in this protocol (previously randomized to Vitamin C)
- No active intervention in this protocol (previously randomized to Placebo)
Treatment groups
225 Participants
are divided into 3 treatment groupsSponsors and collaborators
Oregon Health and Science University
Lead sponsor
Indiana University
Collaborator
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov