CompletedPhase 2/3

Vitamin C to Decrease Effects of Smoking in Pregnancy on Infant Lung Function

United States252 participantsStarted 2012-12

Plain-language summary

Vitamin C supplementation (500 mg per day) given to pregnant women who can not quit smoking will improve the pulmonary function tests in their offspring measured at 3 months of age.

Who can participate

Age range

15 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: At randomization: * Singleton gestation * ≥ 15 years old * Gestational age between 13 and 22 weeks * Receiving prenatal care * Current smoker * English speaking Exclusion Criteria: * Gestational age ≥ 23 and 0/7 weeks * Multiple gestation * Major fetal congenital anomalies * Current use of illicit drugs * Current alcohol abuse * Use of vitamin C (≥ 500 mg/day)\>3 days per week since last menstrual period * Refusal to abstain from vitamin or supplements containing significant vitamin C other than those provided through or approved by study staff * History of kidney stone in patient * Insulin dependent diabetes * Complex maternal medical conditions * Participation in other conflicting research projects * Unable to demonstrate stable method of communication * Pregnancy by in-vitro fertilization * Plan to terminate pregnancy * Failure of medication compliance trial * Failure to return in designated period during placebo run-in * Body mass index \> 50 at screening

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Forced Expiratory Flow at 75% of Expired Volume (FEF75)

Timeframe: 3 months of age

Trial details

NCT IDNCT01723696

SponsorOregon Health and Science University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-04

Results submitted2018-10-15

View on ClinicalTrials.gov More Pulmonary Function; Newborn, Abnormal trials