# VCSIP2: CCC - Lead Application

> **NIH NIH R01** · OREGON HEALTH & SCIENCE UNIVERSITY · 2020 · $1,037,276

## Abstract

Project Summary/Abstract
The beneficial infant outcomes of maternal vitamin C supplementation (500 mg/day) in pregnant smokers is
supported by our robust pre-trial evidence in animal models and convincing human pilot data. This evidence
served as the basis for our current multi-center double blind randomized trial “Vitamin C to Decrease Effects of
Smoking in Pregnancy on Infant Lung Function” (VCSIP; NCT01723696). Recruitment is completed as
scheduled with 252 pregnant smokers randomized to vitamin C or placebo. VCSIP's primary and secondary
outcomes, respectively, are pulmonary function testing (PFT) of infants at 3 months of age, and PFTs and the
incidence of wheeze at 12 months of age. This application is a renewal for the VCSIP trial to continue following
mothers and their offspring through 5 years of age. Time is critical, as the study population is predominantly
under-resourced making rapport crucial to cohort retention, which requires personnel and time.
The aim of this renewal proposal is to determine whether prenatal supplementation with vitamin C can improve
pulmonary function and decrease recurrent wheeze through 5 years of age in the offspring of smokers. Our
hypothesis is that supplemental vitamin C in pregnant smokers will significantly improve their children's
pulmonary function and decrease recurrent wheeze. This is a logical continuation for the VCSIP trial as
transient versus recurrent wheeze are not clinical distinguishable until 5 years of age. Following infants from
the VCSIP until age 5 years: will differentiate patients with transient versus recurrent wheeze (a more likely
predictor of asthma); will determine if early life protective effects of vitamin C are sustained to this older age;
and will provide structure for continued biologic samples from the children for future mechanistic studies of
vitamin C action. All investigators, clinical staff and participants will remain blinded to treatment allocation. We
are currently completing the primary outcome, and based on the number of randomized smokers we will have
a sufficient number of pulmonary function measurements at 3 months of age in the infants of randomized
smokers to meet the predetermined sample size for this analysis. The first infants of VCSIP turned 1 year old
in May 2014; therefore this proposal is being submitted now, prior to the analysis of the primary outcome of the
VCSIP study, to minimize gaps in the follow-up of this valuable cohort. The children will be followed with
quarterly respiratory questionnaires and yearly visits, collecting the following samples: maternal and child hair
for nicotine; child buccal swabs; maternal exhaled carbon monoxide; pulmonary function tests at 3, 4,and 5
years of age. This competitive renewal will allow us to study the longer term outcome of our intervention with
vitamin C with regards to childhood pulmonary function and the occurrence of recurrent wheeze through 5
years of age. It will also allow us to follow this unique, e...

## Key facts

- **NIH application ID:** 9930101
- **Project number:** 5R01HL105447-09
- **Recipient organization:** OREGON HEALTH & SCIENCE UNIVERSITY
- **Principal Investigator:** Cynthia T McEvoy
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $1,037,276
- **Award type:** 5
- **Project period:** 2012-07-15 → 2022-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9930101

## Citation

> US National Institutes of Health, RePORTER application 9930101, VCSIP2: CCC - Lead Application (5R01HL105447-09). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9930101. Licensed CC0.

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