Phase 3
N=252
Vitamin C to Decrease Effects of Smoking in Pregnancy on Infant Lung Function
Pulmonary Function; Newborn, Abnormal · Infant Wheeze · In-utero Nicotine · Second Hand Smoke
Bottom Line
View on ClinicalTrials.gov: NCT01723696 ↗Enrolled (actual)
252
Serious AEs
23.1%
Results posted
Apr 2019
Primary outcome: Primary: Forced Expiratory Flow at 75% of Expired Volume (FEF75) — 188.7; 200.7 ml/s — p=0.19
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Vitamin C +prenatal vitamin (Dietary_supplement); Placebo tablet+prenatal vitamin (Dietary_supplement)
- Age
- Pediatric, Adult, Older Adult · 15+ yrs
- Sex
- Female
- Sponsor
- Oregon Health and Science University
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Forced Expiratory Flow at 75% of Expired Volume (FEF75) |
324; 351.6 | — |
| SECONDARY Forced Expiratory Flow at 75% of Expired Volume (FEF75) |
324; 351.6 | — |
| SECONDARY Incidence of Wheezing Through 12 Months of Age |
63; 51 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01723696). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.