Status:
RECRUITING
Vitamin C to Decrease Effects of Smoking in Pregnancy on Infant Lung Function (VCSIP) Longer Term Follow Up
Lead Sponsor:
Oregon Health and Science University
Collaborating Sponsors:
Indiana University
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Asthma
Pulmonary Function
Eligibility:
All Genders
6-16 years
Brief 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 ...
Detailed Description
The primary outcome of this longitudinal follow-up study is the comparison of airway function tests (specifically the forced expiratory flow between 25%and 75% of expired volume \[FEF25-75\]) measured...
Eligibility Criteria
Inclusion
- 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
- participants who specifically withdraw consent
Key Trial Info
Start Date :
October 11 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2028
Estimated Enrollment :
225 Patients enrolled
Trial Details
Trial ID
NCT06106646
Start Date
October 11 2023
End Date
August 1 2028
Last Update
March 18 2025
Active Locations (2)
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1
Indiana University
Indianapolis, Indiana, United States, 46902
2
Oregon Health and Science University (OHSU)
Portland, Oregon, United States, 97217