Pulmonary Function; Newborn, Abnormal Clinical Trial
— VCSIPOfficial title:
Vitamin C to Decrease Effects of Smoking in Pregnancy on Infant Lung Function
Verified date | March 2019 |
Source | Oregon Health and Science University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 252 |
Est. completion date | December 2017 |
Est. primary completion date | April 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 15 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Indiana University | Indianapolis | Indiana |
United States | Oregon Health & Science University | Portland | Oregon |
Lead Sponsor | Collaborator |
---|---|
Oregon Health and Science University | National Heart, Lung, and Blood Institute (NHLBI), Office of Dietary Supplements (ODS) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Forced Expiratory Flow at 75% of Expired Volume (FEF75) | The primary outcome was the comparison of infant FEFs at 3 months of age obtained using the raised volume rapid thoracic compression (RVRTC) technique in offspring of pregnant smokers randomized to vitamin C versus placebo. The specific primary outcome parameter was the measurement of FEF at 75% of the expired volume (FEF75) | 3 months of age | |
Secondary | Forced Expiratory Flow at 75% of Expired Volume (FEF75) | The measurement of forced expiratory flows and specifically FEF75 will be done at 12 months of age in infants born to pregnant smoking women randomized to vitamin C versus placebo during pregnancy. FEF75 will be measured with the raised volume rapid thoracic compression technique. | 12 months of age | |
Secondary | Incidence of Wheezing Through 12 Months of Age | The incidence of wheezing through 12 months of age will be compared in the infants delivered to smoking pregnant women who were randomized to vitamin C (500 mg) versus placebo during pregnancy. | 12 months of age |
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