Vitamin C to Decrease Effects of Smoking in Pregnancy on Infant Lung Function

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Pulmonary Function; Newborn, Abnormal, Infant Wheeze, In-utero Nicotine, Second Hand Smoke

In brief

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.

Key facts

Study ID

NCT01723696

Run by

Oregon Health and Science University

People needed

252

Starts

2012-12-01

Expected to finish

2017-12-01

Last updated by the study team

2019-04-17

Who can join

Age: 15 and older. Sex: female. Healthy volunteers: accepted.

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
• Failure to return in designated period during placebo run-in
• Body mass index > 50 at screening

Where it is running

• Indiana University — Indianapolis, Indiana, United States
• Oregon Health & Science University — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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