Vitamin C to Decrease the Effects of Smoking in Pregnancy on Infant Lung Function (VCSIP): Rationale, design, and methods of a randomized, controlled trial of vitamin C supplementation in pregnancy for the primary prevention of effects of in utero tobacco smoke exposure on infant lung function and respiratory health.

Autor: McEvoy CT; Department of Pediatrics, Oregon Health & Science University, Portland, OR, USA. Electronic address: mcevoyc@ohsu.edu., Milner KF; Department of Pediatrics, Oregon Health & Science University, Portland, OR, USA., Scherman AJ; Department of Pediatrics, Oregon Health & Science University, Portland, OR, USA., Schilling DG; Department of Pediatrics, Oregon Health & Science University, Portland, OR, USA., Tiller CJ; Department of Pediatrics, Indiana University School of Medicine, Indianapolis, IN, USA., Vuylsteke B; Department of Pediatrics, Oregon Health & Science University, Portland, OR, USA., Shorey-Kendrick LE; Division of Neuroscience, Oregon National Primate Research Center, Beaverton, OR, USA., Spindel ER; Division of Neuroscience, Oregon National Primate Research Center, Beaverton, OR, USA., Schuff R; Department of Medical Informatics and Clinical Epidemiology, Oregon Health & Science University, Portland, OR, USA; Oregon Clinical & Translational Research Institute, Oregon Health & Science University, Portland, OR, USA., Mitchell J; Oregon Clinical & Translational Research Institute, Oregon Health & Science University, Portland, OR, USA., Peters D; Oregon Health & Science University-Portland State University, School of Public Health, Portland, OR, USA., Metz J; Department of Medical Informatics and Clinical Epidemiology, Oregon Health & Science University, Portland, OR, USA., Haas D; Department of Obstetrics and Gynecology, University of Indiana, Indianapolis, IN, USA., Jackson K; PeaceHealth Southwest Medical Center, Vancouver, WA, USA., Tepper RS; Department of Pediatrics, Indiana University School of Medicine, Indianapolis, IN, USA., Morris CD; Department of Medical Informatics and Clinical Epidemiology, Oregon Health & Science University, Portland, OR, USA; Oregon Clinical & Translational Research Institute, Oregon Health & Science University, Portland, OR, USA.
Jazyk: angličtina
Zdroj: Contemporary clinical trials [Contemp Clin Trials] 2017 Jul; Vol. 58, pp. 66-77. Date of Electronic Publication: 2017 May 08.
DOI: 10.1016/j.cct.2017.05.008
Abstrakt: Despite strong anti-smoking efforts, at least 12% of American women cannot quit smoking when pregnant resulting in >450,000 smoke-exposed infants born yearly. Smoking during pregnancy is the largest preventable cause of childhood respiratory illness including wheezing and asthma. Recent studies have shown a protective effect of vitamin C supplementation on the lung function of offspring exposed to in utero smoke in a non-human primate model and an initial human trial. Vitamin C to Decrease the Effects of Smoking in Pregnancy on Infant Lung Function (VCSIP) is a randomized, double-blind, placebo-controlled trial to evaluate pulmonary function at 3months of age in infants delivered to pregnant smokers randomized to 500mg/day of vitamin C versus placebo during pregnancy. Secondary aims evaluate the incidence of wheezing through 12months and pulmonary function testing at 12months of age. Women are randomized between 13 and 23weeks gestation from clinical sites in Portland, Oregon at Oregon Health & Science University and PeaceHealth Southwest Medical Center and in Indianapolis, Indiana at Indiana University and Wishard Hospital. Vitamin C supplementation occurs from randomization to delivery. Monthly contact with participants and monitoring of medical records is performed to document medication adherence, changes in smoking and medical history, and adverse events. Pulmonary function testing of offspring occurs at 3 and 12months of age and incidence of wheezing and respiratory illness through 12months is captured via at least quarterly questionnaires. Ancillary studies are investigating the impact of vitamin C on placental blood flow and DNA methylation.
(Copyright © 2017 Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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