Vitamin C to Decrease Effects of Smoking in Pregnancy on Infant Lung Function
VCSIP
2 other identifiers
interventional
252
1 country
2
Brief Summary
Vitamin C supplementation (500 mg per day) given to pregnant women who can not quit smoking will improve the pulmonary function tests in their offspring measured at 3 months of age.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2012
Longer than P75 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 6, 2012
CompletedFirst Posted
Study publicly available on registry
November 8, 2012
CompletedStudy Start
First participant enrolled
December 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedResults Posted
Study results publicly available
April 17, 2019
CompletedApril 17, 2019
March 1, 2019
3.3 years
November 6, 2012
October 15, 2018
March 28, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Forced Expiratory Flow at 75% of Expired Volume (FEF75)
The primary outcome was the comparison of infant FEFs at 3 months of age obtained using the raised volume rapid thoracic compression (RVRTC) technique in offspring of pregnant smokers randomized to vitamin C versus placebo. The specific primary outcome parameter was the measurement of FEF at 75% of the expired volume (FEF75)
3 months of age
Secondary Outcomes (2)
Forced Expiratory Flow at 75% of Expired Volume (FEF75)
12 months of age
Incidence of Wheezing Through 12 Months of Age
12 months of age
Study Arms (2)
placebo tablet+prenatal vitamin
PLACEBO COMPARATORA daily placebo tablet
Vitamin C +prenatal vitamin
ACTIVE COMPARATOR500 mg vitamin C /day
Interventions
Pregnant smoking women will be randomized to daily vitamin C (500 mg) versus daily placebo
Eligibility Criteria
You may qualify if:
- Singleton gestation
- ≥ 15 years old
- Gestational age between 13 and 22 weeks
- Receiving prenatal care
- Current smoker
- English speaking
You may not qualify if:
- Gestational age ≥ 23 and 0/7 weeks
- Multiple gestation
- Major fetal congenital anomalies
- Current use of illicit drugs
- Current alcohol abuse
- Use of vitamin C (≥ 500 mg/day)\>3 days per week since last menstrual period
- Refusal to abstain from vitamin or supplements containing significant vitamin C other than those provided through or approved by study staff
- History of kidney stone in patient
- Insulin dependent diabetes
- Complex maternal medical conditions
- Participation in other conflicting research projects
- Unable to demonstrate stable method of communication
- Pregnancy by in-vitro fertilization
- Plan to terminate pregnancy
- Failure of medication compliance trial
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Indiana University
Indianapolis, Indiana, 46202-5167, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
Related Publications (4)
Shorey-Kendrick LE, McEvoy CT, Milner K, Harris J, Brownsberger J, Tepper RS, Park B, Gao L, Vu A, Morris CD, Thompson EE, Ober C, Spindel ER. Vitamin C supplementation to pregnant smokers alters asthma- and allergy-associated CpGs in child buccal DNA at 5 years of age. Clin Epigenetics. 2025 Oct 3;17(1):155. doi: 10.1186/s13148-025-01965-2.
PMID: 41044653DERIVEDShorey-Kendrick LE, McEvoy CT, Milner K, Harris J, Brownsberger J, Tepper RS, Park B, Gao L, Vu A, Morris CD, Spindel ER. Improvements in lung function following vitamin C supplementation to pregnant smokers are associated with buccal DNA methylation at 5 years of age. Clin Epigenetics. 2024 Feb 27;16(1):35. doi: 10.1186/s13148-024-01644-8.
PMID: 38413986DERIVEDShorey-Kendrick LE, McEvoy CT, O'Sullivan SM, Milner K, Vuylsteke B, Tepper RS, Haas DM, Park B, Gao L, Vu A, Morris CD, Spindel ER. Impact of vitamin C supplementation on placental DNA methylation changes related to maternal smoking: association with gene expression and respiratory outcomes. Clin Epigenetics. 2021 Sep 19;13(1):177. doi: 10.1186/s13148-021-01161-y.
PMID: 34538263DERIVEDMcEvoy CT, Shorey-Kendrick LE, Milner K, Schilling D, Tiller C, Vuylsteke B, Scherman A, Jackson K, Haas DM, Harris J, Schuff R, Park BS, Vu A, Kraemer DF, Mitchell J, Metz J, Gonzales D, Bunten C, Spindel ER, Tepper RS, Morris CD. Oral Vitamin C (500 mg/d) to Pregnant Smokers Improves Infant Airway Function at 3 Months (VCSIP). A Randomized Trial. Am J Respir Crit Care Med. 2019 May 1;199(9):1139-1147. doi: 10.1164/rccm.201805-1011OC.
PMID: 30522343DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Cindy McEvoy, MD
- Organization
- OHSU
Study Officials
- PRINCIPAL INVESTIGATOR
Cynthia T McEvoy, MD,MCR
Oregon Health and Science University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Pediatrics
Study Record Dates
First Submitted
November 6, 2012
First Posted
November 8, 2012
Study Start
December 1, 2012
Primary Completion
April 1, 2016
Study Completion
December 1, 2017
Last Updated
April 17, 2019
Results First Posted
April 17, 2019
Record last verified: 2019-03