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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Oregon Health and Science University
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Cynthia McEvoy, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01723696
First received: November 6, 2012
Last updated: January 23, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Pulmonary Function; Newborn, Abnormal
Infant Wheeze
In-utero Nicotine
Second Hand Smoke
Dietary Supplement: Vitamin C +prenatal vitamin
Dietary Supplement: Placebo tablet+prenatal vitamin
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: Vitamin C to Decrease Effects of Smoking in Pregnancy on Infant Lung Function

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • 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. [ Time Frame: 3 months of age ] [ Designated as safety issue: No ]
    FEF75 will be measured when the infant is 3 months of age using the raised volume rapid thoracic compression pulmonary function testing technique


Secondary Outcome Measures:
  • Incidence of wheezing through 12 months of age in infants born to pregnant smoking women randomized to vitamin C versus placebo during pregnancy. [ Time Frame: 12 months of age ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Pulmonary function testing at 12 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. [ Time Frame: 12 months of age ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 278
Study Start Date: December 2012
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo tablet+prenatal vitamin
A daily placebo tablet
Dietary Supplement: Placebo tablet+prenatal vitamin
Active Comparator: Vitamin C +prenatal vitamin Dietary Supplement: Vitamin C +prenatal vitamin
Pregnant smoking women will be randomized to daily vitamin C (500 mg) versus daily placebo
Other Name: Ascorbic acid

Detailed Description:

Smoking during pregnancy remains a major public health problem as at least 12% of pregnant women cannot quit smoking during pregnancy. This addiction is the largest preventable cause of childhood respiratory illness, including asthma, and children whose mothers smoked during pregnancy show lifetime decreases in pulmonary function. Smoking is a unique morbidity in that it is addictive, heavily advertised and recent genome studies show there are genotypes that significantly increase the likelihood of being unable to quit. Teen pregnancy, low income, low education, and living with another smoker are important factors increasing the odds of smoking during pregnancy. Pulmonary function tests done shortly after birth in babies born to mothers who smoked during pregnancy show decreased pulmonary function as measured by decreased respiratory flows and respiratory compliance and altered tidal breathing patterns. These changes can still be measured even after the infants have reached adulthood. Multiple epidemiologic studies show that these decreases in pulmonary function lead to increased respiratory disease and costs of hundreds of millions of dollars per year.

The primary aim of this double-blind, placebo controlled, randomized, multi-site study is to demonstrate improved pulmonary function testing at 3 months of age, in infants delivered to smoking mothers who are randomized to 500 mg/day of supplemental vitamin C versus placebo at less than or equal to 22 weeks of pregnancy. We will recruit 278 smoking pregnant women into the study. Patients will meet with research personnel at each prenatal visit and smoking cessation will be actively encouraged. Patients will be monitored with a set of serial biomarkers to assess smoking and medication compliance, including urine cotinine levels, smoking questionnaires, pill counts and fasting plasma ascorbic acid levels. Pulmonary function tests will be done at 3 months of age and will measure forced expiratory flows. The infants will also be followed through one year of age with monthly validated respiratory questionnaires and a follow-up pulmonary function test at 12 months of age. Success of this study is supported by strong pilot data showing statistically significant improvements at about 48 hours of age in pulmonary function tests in infants born to smoking mothers who received vitamin C versus placebo, and preliminary data showing a lower incidence of wheezing at 12 months of age in these infants. Key genetic polymorphisms shown to increase sensitivity to in-utero smoke exposure will also be measured. The success of this study is also supported by animal models showing the effectiveness of vitamin C to preserve pulmonary function and genetic and epidemiologic studies linking the effects of smoking during pregnancy to oxidant mechanisms. The secondary aims of the study include: 1) to demonstrate a decreased incidence of wheezing through 12 months of age in infants delivered to smoking mothers who are randomized to 500mg/day of supplemental vitamin C versus placebo during pregnancy; 2) to demonstrate improved pulmonary function tests at 12 months of age in these infants.

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01723696

Contacts
Contact: Cindy T McEvoy, MD, MCR 503-494-0085 mcevoyc@ohsu.edu
Contact: Kristin Milner, BS, CMA 503-494-5598 milner@ohsu.edu

Locations
United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202-5167
Contact: Robert S Tepper, MD, PhD    317-274-9647    rtepper@iupui.edu   
Contact: Rose Melvin, RN    317-948-7607    rmelvin@iupui.edu   
Principal Investigator: Robert S Tepper, MD, PhD         
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Cynthia T McEvoy, MD,MCR    503-494-0085    mcevoyc@ohsu.edu   
Contact: Kristin Milner, BS, CMA    503-494-5598    milner@ohsu.edu   
Principal Investigator: Cynthia T McEvoy, MD, MCR         
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: Cynthia T McEvoy, MD,MCR Oregon Health and Science University
  More Information

No publications provided

Responsible Party: Cynthia McEvoy, Associate Professor of Pediatrics, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01723696     History of Changes
Other Study ID Numbers: HL105447, R01HL105447
Study First Received: November 6, 2012
Last Updated: January 23, 2013
Health Authority: United States: Institutional Review Board
United States: Data and Safety Monitoring Board

Keywords provided by Oregon Health and Science University:
In-utero smoke;
Pulmonary function testing;
Wheeze;
Vitamin C;
Forced expiratory flows

Additional relevant MeSH terms:
Ascorbic Acid
Vitamins
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on July 23, 2014