Phase 3
Completed 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
Source: ClinicalTrials.gov NCT01723696 ↗
Enrolled (actual)
252
Serious AEs
23.1%
Results posted
Apr 2019
Primary outcomePrimary: Forced Expiratory Flow at 75% of Expired Volume (FEF75) — 188.7; 200.7 ml/s — p=0.19
◆ Published Evidence
Established
53citations · ~8 / year
Oral Vitamin C (500 mg/d) to Pregnant Smokers Improves Infant Airway Function at 3 Months (VCSIP). A Randomized Trial.
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.
Linked Publications (4)
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Oral Vitamin C (500 mg/d) to Pregnant Smokers Improves Infant Airway Function at 3 Months (VCSIP). A Randomized Trial.
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Impact of vitamin C supplementation on placental DNA methylation changes related to maternal smoking: association with gene expression and respiratory outcomes.
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Improvements in lung function following vitamin C supplementation to pregnant smokers are associated with buccal DNA methylation at 5 years of age.
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Vitamin C supplementation to pregnant smokers alters asthma- and allergy-associated CpGs in child buccal DNA at 5 years of age.
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.