NCT00632476

Brief Summary

Women who smoke during their pregnancy place their unborn child at an increased risk of health problems, including decreased lung function and possible lung diseases later in life. Preliminary animal research suggests that if vitamin C is taken during pregnancy, nicotine's harmful effects on the unborn baby's developing lungs may be blocked. This study will determine the effect that vitamin C has on the lung development and function of babies born to women who smoke during pregnancy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
282

participants targeted

Target at P50-P75 for not_applicable pregnancy

Timeline
Completed

Started Mar 2007

Longer than P75 for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 1, 2007

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

March 5, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 10, 2008

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

September 4, 2013

Status Verified

August 1, 2013

Enrollment Period

4.3 years

First QC Date

March 5, 2008

Last Update Submit

August 31, 2013

Conditions

PregnancySmoking

Keywords

Smoking During PregnancyVitamin CNewborn Lung FunctionAscorbic Acid

Outcome Measures

Primary Outcomes (1)

  • Pulmonary function testing (including respiratory compliance and the ratio of time to peak tidal expiratory flow to total expiratory time)

    Measured within 48 hours after delivery

Secondary Outcomes (1)

  • Pulmonary function testing (including respiratory compliance and the ratio of time to peak tidal expiratory flow to total expiratory time)and respiratory history including wheezing through 12 months of age.

    Measured at 12 months of age

Study Arms (3)

A

PLACEBO COMPARATOR

Participants will receive a placebo capsule throughout pregnancy.

Other: Placebo

B

ACTIVE COMPARATOR

Participants will receive a vitamin C capsule throughout pregnancy.

Dietary Supplement: Vitamin C

C

NO INTERVENTION

A group of non-smoking pregnant women will not receive placebo or vitamin C.

Interventions

PlaceboOTHER

Placebo capsule once a day

Also known as: Sugar pill
A
Vitamin CDIETARY_SUPPLEMENT

A 500-mg vitamin C capsule once a day

Also known as: Ascorbic acid
B

Eligibility Criteria

Age15 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Randomly assigned to a study intervention at less than 22 weeks of gestation
  • History of smoking
  • Singleton gestation pregnancy
  • Smoking cessation intervention offered but declined

You may not qualify if:

  • Multiple gestation pregnancy
  • Documented major fetal congenital anomalies
  • History of kidney stones
  • Insulin dependent diabetes
  • Current participation in other research projects that may interfere with this study
  • Continuous use of high dose vitamin C since last menstrual period (LMP) or initial ascorbic acid level greater than 100 micromoles/liter

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97266, United States

Location

Related Publications (3)

  • Shorey-Kendrick LE, McEvoy CT, Ferguson B, Burchard J, Park BS, Gao L, Vuylsteke BH, Milner KF, Morris CD, Spindel ER. Vitamin C Prevents Offspring DNA Methylation Changes Associated with Maternal Smoking in Pregnancy. Am J Respir Crit Care Med. 2017 Sep 15;196(6):745-755. doi: 10.1164/rccm.201610-2141OC.

    PMID: 28422514DERIVED

  • McEvoy CT, Schilling D, Clay N, Jackson K, Go MD, Spitale P, Bunten C, Leiva M, Gonzales D, Hollister-Smith J, Durand M, Frei B, Buist AS, Peters D, Morris CD, Spindel ER. Vitamin C supplementation for pregnant smoking women and pulmonary function in their newborn infants: a randomized clinical trial. JAMA. 2014 May;311(20):2074-82. doi: 10.1001/jama.2014.5217.

    PMID: 24838476DERIVED

  • Didenco S, Gillingham MB, Go MD, Leonard SW, Traber MG, McEvoy CT. Increased vitamin E intake is associated with higher alpha-tocopherol concentration in the maternal circulation but higher alpha-carboxyethyl hydroxychroman concentration in the fetal circulation. Am J Clin Nutr. 2011 Feb;93(2):368-73. doi: 10.3945/ajcn.110.008367. Epub 2010 Dec 15.

    PMID: 21159788DERIVED

MeSH Terms

Conditions

Smoking

Interventions

SugarsAscorbic Acid

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

CarbohydratesSugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy Acids

Study Officials

  • Cynthia T. McEvoy, MD

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
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

March 5, 2008

First Posted

March 10, 2008

Study Start

March 1, 2007

Primary Completion

July 1, 2011

Study Completion

July 1, 2012

Last Updated

September 4, 2013

Record last verified: 2013-08

Locations

US(1)