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临床试验/NCT03203603
NCT03203603已完成不适用

Vitamin C to Decrease the Effects of Smoking in Pregnancy on Infant Lung Function (VCSIP): Follow-up of a Randomized Trial

Oregon Health and Science University2 个研究点 分布在 1 个国家目标入组 242 人开始时间: 2017年3月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
242
试验地点
2
主要终点
Improved pulmonary function, spirometry

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
6 Months 至 4 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • Patients specifically withdrawing consent.

结局指标

主要结局

Improved pulmonary function, spirometry

时间窗: 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.

次要结局

  • Decreased incidence of wheeze(5 years of age)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Cynthia McEvoy

MD, MCR

Oregon Health and Science University

研究点 (2)

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