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NCT03206710 · ClinicalTrials.gov registry record
Vitamin C Supplementation to Pregnant Smokers: Follow-up of 2 Randomized Trials Plus Changes in DNA Methylation
A clinical trial of Asthma and Wheezing, sponsored by Oregon Health and Science University.
- Completed
- Registry status
- 395
- Enrollment target
- 2
- Study locations
NCT03206710: Completed study of Asthma and Wheezing, sponsored by Oregon Health and Science University.
NCT03206710 is a study of Asthma and Wheezing that has completed, run by Oregon Health and Science University. The registered enrollment target is 395 participants, below the 1,562-participant average among 374 other Asthma trials with a reported enrollment target (75% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03206710, a study of Asthma and Wheezing, has completed, sponsored by Oregon Health and Science University.
- COMPLETED
- Registry status
- 395 participants
- Enrollment target
- 2
- Study locations
Study Summary
In a randomized clinical trial (RCT) published in JAMA, the investigators have provided evidence that vitamin C supplementation (500 mg daily during pregnancy) ameliorates the effects of maternal smoking during pregnancy on offspring lung function and subsequent incidence of wheeze by 48% through 1 year of age. The investigators are currently completing a second RCT of vitamin C supplementation in pregnant smokers with more robust measures of pulmonary outcomes. The purpose of this ECHO application is to combine these 2 focused, interventional cohorts to allow critical longitudinal follow-up of respiratory outcomes in these children including the study of pulmonary function test (PFT) trajectories and incidence of recurrent wheeze/asthma from infancy through early adolescence in offspring of pregnant smokers randomized to vitamin C versus placebo.
Primary Outcome
The first primary aim of this study is to demonstrate improved pulmonary function trajectories as measured with forced expiratory flows through 15 years of age in the offspring of pregnant smokers randomized to vitamin C (500 mg/day) versus placebo.
Conditions Studied
Interventions
- OTHER No current intervention
Study Locations (2)
Indiana
- Indiana University - Indianapolis
Oregon
- Oregon Health and Science University - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 395 participants |
| Start Date | 2017-06-01 |
| Est. Completion | 2024-12-31 |
What the finished NCT03206710 record still lists
NCT03206710 is an observational study that tracks outcomes without assigning an intervention. The registered 395 participants enrollment target is mid-sized for trials with a published cap, below the 1,562-participant average among 374 other Asthma trials with a reported enrollment target (75% lower).
The record links to 4 conditions, with Asthma appearing as the primary indexed condition, and to 1 intervention - of which No current intervention is the first listed.
NCT03206710 reports a single indexed study location in Indiana, Oregon.
Frequently Asked Questions
What is clinical trial NCT03206710 about?
NCT03206710 is a clinical study titled "Vitamin C Supplementation to Pregnant Smokers: Follow-up of 2 Randomized Trials Plus Changes in DNA Methylation". In a randomized clinical trial (RCT) published in JAMA, the investigators have provided evidence that vitamin C supplementation (500 mg daily during pregnancy) ameliorates the effects of maternal smoking during pregnancy on offspring lung function and subsequent incidence of wheeze by 48% through 1 ...
What is the current status of trial NCT03206710?
This trial is currently completed. The enrollment target is 395 participants. The study started on 2017-06-01. Estimated completion is 2024-12-31.
What conditions does trial NCT03206710 study?
This clinical trial studies the following conditions: Asthma, Wheezing, Pulmonary Function, In Utero Nicotine.
What interventions are being tested in trial NCT03206710?
The interventions under investigation include: No current intervention (OTHER).
Who is sponsoring clinical trial NCT03206710?
This trial is sponsored by Oregon Health and Science University, which has 546 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03206710 being conducted?
This trial has 2 study locations across Indiana, Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03206710's enrollment target sits among peer trials
395 96th of 374 higher than 278 of 374 other Asthma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Asthma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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