Status:

COMPLETED

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

Lead Sponsor:

Oregon Health and Science University

Collaborating Sponsors:

National Heart, Lung, and Blood Institute (NHLBI)

National Institute of Environmental Health Sciences (NIEHS)

Conditions:

Pregnancy

Smoking

Eligibility:

FEMALE

15+ years

Phase:

NA

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 ...

Detailed Description

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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

March 1 2007

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 1 2012

Estimated Enrollment :

282 Patients enrolled

Trial Details

Trial ID

NCT00632476

Start Date

March 1 2007

End Date

July 1 2012

Last Update

September 4 2013

Active Locations (1)

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Oregon Health & Science University

Portland, Oregon, United States, 97266