Vitamin C Supplementation for Pregnant Smoking Women and Pulmonary Function in their Newborn Infants: A Randomized Clinical Trial
Abstract
Importance Maternal smoking during pregnancy adversely affects offspring lung development with lifelong decreases in pulmonary function and increased asthma risk. In a primate model, vitamin C blocked some of the in-utero effects of nicotine on lung development and offspring pulmonary function. Objective To determine if newborns of pregnant smokers randomized to daily vitamin C would have improved pulmonary function tests (PFTs) and decreased wheezing compared to those randomized to placebo. Design, Setting, Participants, Intervention Randomized, double-blind trial in three sites in the Pacific Northwest. Between March 2007 and January 2011, 206 pregnant smokers were recruited and 179 randomized to vitamin C (500 mg/day) versus placebo (89 to vitamin C and 90 to placebo). 159 newborns of randomized pregnant smokers (76 vitamin C treated and 83 placebo treated) and 76 of pregnant nonsmokers were studied with newborn PFTs. Follow-up assessment including wheezing was assessed through one year of age and PFTs were done at one year of age. Main Outcomes and Measures The primary outcome was measurements of newborn pulmonary function (specifically the ratio of the time to peak tidal expiratory flow to expiratory time [TPTEF:TE] and passive respiratory compliance per kilogram [Crs/kg]) within 72 hours of age. Secondary outcomes included incidence of wheezing through one year of age and PFTs at one year of age. A subgroup of pregnant smokers and nonsmokers had genotyping performed.…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 83 participants or records.
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