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VCSIP Follow-up Study (VCSIPRenewal)

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ClinicalTrials.gov Identifier: NCT03203603
Recruitment Status : Recruiting
First Posted : June 29, 2017
Last Update Posted : October 17, 2018
Sponsor:
Collaborators:
Indiana University
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Cynthia McEvoy, Oregon Health and Science University

Brief Summary:
The overall aims of this protocol are to determine whether prenatal supplementation with vitamin C to pregnant smokers can improve pulmonary function and decrease wheeze at 5 years of age in their offspring. This is a continuation of the VCSIP trial, to follow the offspring through 5 years of age. The hypothesis for this protocol is an extension of the VCSIP trial that supplemental vitamin C in pregnant smokers can significantly improve their children's PFTs and decrease the incidence of wheeze.

Condition or disease Intervention/treatment
Asthma Pulmonary Function Wheezing In Utero Nicotine Other: No active intervention

Detailed Description:

The overall aims of this protocol are to determine whether prenatal supplementation with vitamin C to pregnant smokers can improve pulmonary function and decrease wheeze at 5 years of age in their offspring. This is a continuation of the VCSIP trial, to follow the offspring through 5 years of age. The hypothesis for this protocol is an extension of the VCSIP trial that supplemental vitamin C in pregnant smokers can significantly improve their children's PFTs and decrease the incidence of wheeze. The reasons for this protocol are to follow the children born to mothers randomized in the VCSIP to the age of 5 to differentiate the patients with transient versus recurrent wheeze (and therefore more likely to develop asthma); to determine if early protective effects of vitamin C are sustained to this older age; and to continue to collect biologic samples from the children for future mechanistic studies of vitamin C action.

The primary aim of this study is to demonstrate improved pulmonary function at 5 years of age in the offspring of pregnant smokers randomized to vitamin C (500 mg/day) versus placebo. The investigators hypothesize that vitamin C supplementation in pregnancy will block the adverse effects of maternal smoking on offspring pulmonary function measured at 5 years of age by spirometry. Impulse oscillometry (IOS) will also be used at 3-5 years of age to assess pulmonary function.

Specific Aim 2 (Secondary Outcome): The secondary aim of this study is to demonstrate a decreased incidence of wheeze at 5 years of age in offspring of pregnant smokers randomized to vitamin C (500 mg/day) versus placebo. The investigators hypothesize that vitamin C supplementation during pregnancy will decrease the incidence of wheeze at 5 years of age in offspring of smokers. Respiratory health will be assessed by quarterly validated respiratory questionnaires and clinician report.


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Study Type : Observational
Estimated Enrollment : 240 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Vitamin C to Decrease the Effects of Smoking in Pregnancy on Infant Lung Function (VCSIP): Follow-up of a Randomized Trial
Actual Study Start Date : March 27, 2017
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin C

Group/Cohort Intervention/treatment
Offspring of smokers who got vitamin C
Offspring of pregnant smokers randomized to vitamin C during the initial randomized portion of the VCSIP study
Other: No active intervention
This is a follow-up of a randomized trial. No active intervention is being given in the follow-up.

Offspring of smokers who got placebo
Offspring of pregnant smokers randomized to placebo during the initial randomized portion of the VCSIP study
Other: No active intervention
This is a follow-up of a randomized trial. No active intervention is being given in the follow-up.

Offspring of pregnant non-smokers
Offspring of pregnant non-smokers who were followed in a similar fashion during pregnancy as the randomized pregnant smokers
Other: No active intervention
This is a follow-up of a randomized trial. No active intervention is being given in the follow-up.




Primary Outcome Measures :
  1. Improved pulmonary function, spirometry [ Time Frame: 5 years of age ]
    The primary aim of this study is to demonstrate improved pulmonary function at 5 years of age in the offspring of pregnant smokers randomized to vitamin C 500 mg/day versus placebo.


Secondary Outcome Measures :
  1. Decreased incidence of wheeze [ Time Frame: 5 years of age ]
    The secondary aim of this study is to demonstrate a decreased incidence of wheeze at 5 year of age in offspring of pregnant smokers randomized to vitamin C (500 mg/day) versus placebo


Biospecimen Retention:   Samples With DNA
buccal swabs, hair, blood and urine will be collected.


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 4 Years   (Child)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
This is a follow up of NCT01723696. In that study, pregnant smokers were recruited at obstetric clinics delivering at OHSU, PeaceHealth Southwest Washington Medical Center in Vancouver, Washington or Indiana University in Indianapolis, Indiana. We are now following the offspring of those pregnant smokers (and control group non-smokers).
Criteria

Inclusion Criteria:

  • Women and their offspring randomized to vitamin C versus placebo during pregnancy as well as pregnant nonsmokers and their offspring enrolled as the reference group in the current RCT.

Exclusion Criteria:

  • Patients specifically withdrawing consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03203603


Contacts
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Contact: Cindy McEvoy, MD, MCR 503-494-0085 mcevoyc@ohsu.edu
Contact: Kristin Milner, BA, CMA 971-404-8667 milner@ohsu.edu

Locations
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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: Christina Tiller, RRT         
Principal Investigator: Robert S Tepper, MD, PhD         
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Cindy McEvoy, MD, MCR    503-494-0085    mcevoyc@ohsu.edu   
Contact: Kristin Milner, BA, CMA    971-404-8667    milner@ohsu.edu   
Sponsors and Collaborators
Oregon Health and Science University
Indiana University
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Cindy McEvoy, MD, MCR Oregon Health and Science University

Publications:
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Responsible Party: Cynthia McEvoy, MD, MCR, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT03203603     History of Changes
Other Study ID Numbers: VCSIP-Renewal
First Posted: June 29, 2017    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Cynthia McEvoy, Oregon Health and Science University:
asthma
pulmonary function testing
wheeze
vitamin C
antioxidants
forced expiratory flows

Additional relevant MeSH terms:
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Respiratory Sounds
Signs and Symptoms, Respiratory
Signs and Symptoms
Vitamins
Ascorbic Acid
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents