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Evaluating the Effects of Supplemental Vitamin C on Infant Lung Function in Pregnant Smoking Women

NCT ID: NCT00632476

Last Updated: 2013-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

282 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2012-07-31

Brief Summary

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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.

Detailed Description

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Approximately 12% of women smoke during pregnancy, and at least 500,000 babies are born each year having been exposed to nicotine. These infants have poor lung function at birth and have an increased risk of developing lung diseases, including bronchitis, pneumonia, and asthma. Researchers believe that nicotine may interact with nicotinic receptors in the unborn child's developing lungs and cause altered growth and decreased lung function. Preliminary animal research studies suggest that some of the harmful effects of nicotine may be blocked by vitamin C, an antioxidant that may protect against cellular damage caused by nicotine and other pollutants. The purpose of this study is to evaluate the effectiveness of vitamin C at blocking the harmful effects of nicotine exposure on lung development and function in children born to women who smoke during pregnancy.

This study will enroll pregnant women who smoke, as well as a control group of pregnant women who do not smoke. At a baseline study visit, all participants will complete smoking history questionnaires. For 2 weeks, all participants who smoke will receive placebo capsules once a day. They will then be randomly assigned to receive either vitamin C capsules or placebo capsules, both of which will be taken once a day, in addition to a prenatal vitamin, for the duration of their pregnancy. Study visits, occurring once a month throughout the pregnancy, will include a medical and smoking history review and urine collection. An ultrasound exam will be performed once during the pregnancy to determine the exact size and age of the baby, and blood collection will occur at baseline and once or twice more during the pregnancy. Study researchers will review participants' medical records and will call participants three times during their pregnancy to review their food intake. At the time of delivery, amniotic fluid samples will be collected. When babies are 48 hours old, baby lung function testing will occur, and when babies are 3 and 9 months of age, researchers will call participants to collect breathing information on the babies. When babies are 12 months old, participants will attend a study visit that will include urine collection from the babies and a review of baby breathing difficulties, medication changes, and environmental smoking exposure.

Conditions

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Pregnancy Smoking

Keywords

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Smoking During Pregnancy Vitamin C Newborn Lung Function Ascorbic Acid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A

Participants will receive a placebo capsule throughout pregnancy.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo capsule once a day

B

Participants will receive a vitamin C capsule throughout pregnancy.

Group Type ACTIVE_COMPARATOR

Vitamin C

Intervention Type DIETARY_SUPPLEMENT

A 500-mg vitamin C capsule once a day

C

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Placebo

Placebo capsule once a day

Intervention Type OTHER

Vitamin C

A 500-mg vitamin C capsule once a day

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Sugar pill Ascorbic acid

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

15 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

National Institute of Environmental Health Sciences (NIEHS)

NIH

Sponsor Role collaborator

Oregon Health and Science University

OTHER

Sponsor Role lead

Responsible Party

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Cynthia McEvoy

Associate Professor of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cynthia T. McEvoy, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

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Oregon Health & Science University

Portland, Oregon, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 28422514 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24838476 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21159788 (View on PubMed)

Other Identifiers

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K23HL080231

Identifier Type: NIH

Identifier Source: secondary_id

View Link

K23HL080231-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

546

Identifier Type: -

Identifier Source: org_study_id