Vitamin C to Decrease Effects of Smoking in Pregnancy on Infant Lung Function (VCSIP) Longer Term Follow Up

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Oregon Health and Science University
Study ID
NCT06106646
Status
Recruiting
Apply to this trial

Conditions

  • Asthma
  • In Utero Nicotine
  • Pulmonary Function
  • Wheezing

Eligibility Criteria

Sex
ALL
Age
6 Years - 16 Years
Healthy Volunteers
Not accepted

Interventions

  • No active intervention in this protocol (previously randomized to Vitamin C) — DIETARY_SUPPLEMENT
    In the original VCSIP study, pregnant women were randomized to receive either extra Vitamin C every day (500mg/day) or placebo. This trial is a follow-up trial with no active intervention.
  • No active intervention in this protocol (previously randomized to Placebo) — OTHER
    In the original VCSIP study, pregnant women were randomized to receive either extra Vitamin C every day (500mg/day) or placebo. This trial is a follow-up trial with no active intervention.

Study Details

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.

Key Dates

Start date
Oct 11, 2023
Status verified
Mar 2025
Primary completion
Aug 31, 2027
Completion
Aug 31, 2028

Study Design

Enrollment
225 participants (estimated)

Arms

  • Arm: Offspring of smokers who received Vitamin C
    In the original VCSIP study, pregnant women were randomized to receive either extra Vitamin C every day (500mg/day) or placebo.
  • Arm: Offspring of smokers who received Placebo
    In the original VCSIP study, pregnant women were randomized to receive either extra Vitamin C every day (500mg/day) or placebo.
  • Arm: Offspring of non-smokers

Primary Outcome Measure

Sustained improvement in pulmonary function and trajectory [ Time Frame: 10 years of age ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Indiana UniversityIndianapolisIndiana46902
Christina Tiller
[email protected]
Robert Tepper, MD (PRINCIPAL_INVESTIGATOR)
Oregon Health and Science University (OHSU)PortlandOregon97217
Kristin Milner
[email protected]
971-404-0223
Cindy McEvoy, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Indianapolis, IN

By condition
Asthma
By specialty
PulmonologyLung disease
By research site
Indiana University· Indianapolis, INOregon Health and Science University (OHSU)· Portland, OR

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