Pulmonary Function; Newborn, Abnormal | Vitamin C to Decrease Effects of Smoking in Pregnancy on Infant Lung Function
Pulmonary Function; Newborn, Abnormal research study
What is the primary objective of this study?
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.
Who is eligible to participate?
Inclusion Criteria: At randomization: - Singleton gestation - ≥ 15 years old - Gestational age between 13 and 22 weeks - Receiving prenatal care - Current smoker - English speaking Exclusion Criteria: - 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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Pulmonary Function; Newborn, Abnormal
Second Hand Smoke
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Dietary Supplement:Vitamin C +prenatal vitaminPregnant smoking women will be randomized to daily vitamin C (500 mg) versus daily placebo
Dietary Supplement:Placebo tablet+prenatal vitamin
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
placebo tablet+prenatal vitaminA daily placebo tablet
Vitamin C +prenatal vitamin
Start Date: December 2012
Completed Date: December 2017
Phase: Phase 2/Phase 3
Primary Outcome: Pulmonary function testing at 3 months of age in infants born to smoking pregnant women randomized to daily vitamin C versus placebo. The measurement of forced expiratory flow at 75% of expired volume (FEF75)will be compared between the groups.
Secondary Outcome: Incidence of wheezing through 12 months of age in infants born to pregnant smoking women randomized to vitamin C versus placebo during pregnancy.
Study sponsors, principal investigator, and references
Principal Investigator: Cynthia T McEvoy, MD,MCR
Lead Sponsor: Oregon Health and Science University
Collaborator: National Heart, Lung, and Blood Institute (NHLBI)