PregnancyNCT00632476
Evaluating the Effects of Supplemental Vitamin C on Infant Lung Function in Pregnant Smoking Women
A study testing Vitamin C in people with Pregnancy and Smoking, run by Oregon Health and Science University at 1 site in United States.
Trial summary
Women who smoke during their pregnancy place their unborn child at an increased risk of health problems, including decreased lung function and possible lung diseases later in life. Read more about this study
- Who is it for?
- Ages 15 years and older, women onlyHealthy volunteers can take part
- What is being tested?
- Vitamin C
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 282 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Jul 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Randomly assigned to a study intervention at less than 22 weeks of gestation
- History of smoking
- Singleton gestation pregnancy
- Smoking cessation intervention offered but declined
Who cannot join
- Multiple gestation pregnancy
- Documented major fetal congenital anomalies
- History of kidney stones
- Insulin dependent diabetes
- Current participation in other research projects that may interfere with this study
- Continuous use of high dose vitamin C since last menstrual period (LMP) or initial ascorbic acid level greater than 100 micromoles/liter
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97266
About this study
Official title: In-Utero Smoke, Vitamin C, and Newborn Lung Function
Women who smoke during their pregnancy place their unborn child at an increased risk of health problems, including decreased lung function and possible lung diseases later in life. Preliminary animal research suggests that if vitamin C is taken during pregnancy, nicotine's harmful effects on the unborn baby's developing lungs may be blocked. This study will determine the effect that vitamin C has on the lung development and function of babies born to women who smoke during pregnancy.
Read the detailed description
Approximately 12% of women smoke during pregnancy, and at least 500,000 babies are born each year having been exposed to nicotine. These infants have poor lung function at birth and have an increased risk of developing lung diseases, including bronchitis, pneumonia, and asthma. Researchers believe that nicotine may interact with nicotinic receptors in the unborn child's developing lungs and cause altered growth and decreased lung function. Preliminary animal research studies suggest that some of the harmful effects of nicotine may be blocked by vitamin C, an antioxidant that may protect against cellular damage caused by nicotine and other pollutants. The purpose of this study is to evaluate the effectiveness of vitamin C at blocking the harmful effects of nicotine exposure on lung development and function in children born to women who smoke during pregnancy.
This study will enroll pregnant women who smoke, as well as a control group of pregnant women who do not smoke. At a baseline study visit, all participants will complete smoking history questionnaires. For 2 weeks, all participants who smoke will receive placebo capsules once a day. They will then be randomly assigned to receive either vitamin C capsules or placebo capsules, both of which will be taken once a day, in addition to a prenatal vitamin, for the duration of their pregnancy. Study visits, occurring once a month throughout the pregnancy, will include a medical and smoking history review and urine collection. An ultrasound exam will be performed once during the pregnancy to determine the exact size and age of the baby, and blood collection will occur at baseline and once or twice more during the pregnancy. Study researchers will review participants' medical records and will call participants three times during their pregnancy to review their food intake. At the time of delivery, amniotic fluid samples will be collected. When babies are 48 hours old, baby lung function testing will occur, and when babies are 3 and 9 months of age, researchers will call participants to collect breathing information on the babies. When babies are 12 months old, participants will attend a study visit that will include urine collection from the babies and a review of baby breathing difficulties, medication changes, and environmental smoking exposure.
- Being tested
- Placebo, Vitamin C
- Keywords
- Smoking During Pregnancy, Vitamin C, Newborn Lung Function, Ascorbic Acid
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
Also called Sugar pill
Placebo capsule once a day
Vitamin CDietary supplement
Also called Ascorbic acid
A 500-mg vitamin C capsule once a day
| Study group | Role | What they receive |
|---|---|---|
| A | Placebo comparator | Participants will receive a placebo capsule throughout pregnancy. Receives: Other: Placebo |
| B | Active comparator | Participants will receive a vitamin C capsule throughout pregnancy. Receives: Dietary Supplement: Vitamin C |
| C | No intervention | A group of non-smoking pregnant women will not receive placebo or vitamin C. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary function testing (including respiratory compliance and the ratio of time to peak tidal expiratory flow to total expiratory time)
Measured: Measured within 48 hours after delivery
Secondary outcomes (1)
Pulmonary function testing (including respiratory compliance and the ratio of time to peak tidal expiratory flow to total expiratory time)and respiratory history including wheezing through 12 months of age.
Measured: Measured at 12 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2008 (estimated)
- Study startMar 2007
- Primary completionJul 2011
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 282 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), National Institute of Environmental Health Sciences (NIEHS)
- Responsible party
- Principal investigator, Cynthia McEvoy, National Heart, Lung, and Blood Institute (NHLBI)
- Investigators
- Cynthia T. McEvoy, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00632476
- Sponsor's protocol ID
- 546
- Other IDs
- K23HL080231, K23HL080231-01A1
- Status last verified
- Aug 2013
- First submitted
- 5 Mar 2008
- Last updated
- 4 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Shorey-Kendrick LE, McEvoy CT, Ferguson B, Burchard J, Park BS, Gao L, Vuylsteke BH, Milner KF, Morris CD, Spindel ER. Vitamin C Prevents Offspring DNA Methylation Changes Associated with Maternal Smoking in Pregnancy. Am J Respir Crit Care Med. 2017 Sep 15;196(6):745-755. doi: 10.1164/rccm.201610-2141OC.
PubMed 28422514McEvoy CT, Schilling D, Clay N, Jackson K, Go MD, Spitale P, Bunten C, Leiva M, Gonzales D, Hollister-Smith J, Durand M, Frei B, Buist AS, Peters D, Morris CD, Spindel ER. Vitamin C supplementation for pregnant smoking women and pulmonary function in their newborn infants: a randomized clinical trial. JAMA. 2014 May;311(20):2074-82. doi: 10.1001/jama.2014.5217.
PubMed 24838476Didenco S, Gillingham MB, Go MD, Leonard SW, Traber MG, McEvoy CT. Increased vitamin E intake is associated with higher alpha-tocopherol concentration in the maternal circulation but higher alpha-carboxyethyl hydroxychroman concentration in the fetal circulation. Am J Clin Nutr. 2011 Feb;93(2):368-73. doi: 10.3945/ajcn.110.008367. Epub 2010 Dec 15.
PubMed 21159788
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In-Utero Smoke, Vitamin C, and Newborn Lung Function
- ClinicalTrials.gov ID
- NCT00632476
- Acronym / sponsor ID
- 546
- Keywords
- Smoking During Pregnancy, Vitamin C, Newborn Lung Function, Ascorbic Acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 282 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), National Institute of Environmental Health Sciences (NIEHS)
- Study start
- Mar 2007
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 10 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Women who smoke during their pregnancy place their unborn child at an increased risk of health problems, including decreased lung function and possible lung diseases later in life. Preliminary animal research suggests that if vitamin C is taken during pregnancy, nicotine's harmful effects on the unborn baby's developing lungs may be blocked. This study will determine the effect that vitamin C has on the lung development and function of babies born to women who smoke during pregnancy.
Detailed description
Approximately 12% of women smoke during pregnancy, and at least 500,000 babies are born each year having been exposed to nicotine. These infants have poor lung function at birth and have an increased risk of developing lung diseases, including bronchitis, pneumonia, and asthma. Researchers believe that nicotine may interact with nicotinic receptors in the unborn child's developing lungs and cause altered growth and decreased lung function. Preliminary animal research studies suggest that some of the harmful effects of nicotine may be blocked by vitamin C, an antioxidant that may protect against cellular damage caused by nicotine and other pollutants. The purpose of this study is to evaluate the effectiveness of vitamin C at blocking the harmful effects of nicotine exposure on lung development and function in children born to women who smoke during pregnancy.
This study will enroll pregnant women who smoke, as well as a control group of pregnant women who do not smoke. At a baseline study visit, all participants will complete smoking history questionnaires. For 2 weeks, all participants who smoke will receive placebo capsules once a day. They will then be randomly assigned to receive either vitamin C capsules or placebo capsules, both of which will be taken once a day, in addition to a prenatal vitamin, for the duration of their pregnancy. Study visits, occurring once a month throughout the pregnancy, will include a medical and smoking history review and urine collection. An ultrasound exam will be performed once during the pregnancy to determine the exact size and age of the baby, and blood collection will occur at baseline and once or twice more during the pregnancy. Study researchers will review participants' medical records and will call participants three times during their pregnancy to review their food intake. At the time of delivery, amniotic fluid samples will be collected. When babies are 48 hours old, baby lung function testing will occur, and when babies are 3 and 9 months of age, researchers will call participants to collect breathing information on the babies. When babies are 12 months old, participants will attend a study visit that will include urine collection from the babies and a review of baby breathing difficulties, medication changes, and environmental smoking exposure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Placebo comparator | Other: PlaceboParticipants will receive a placebo capsule throughout pregnancy. |
| B | Active comparator | Dietary Supplement: Vitamin CParticipants will receive a vitamin C capsule throughout pregnancy. |
| C | No intervention | –A group of non-smoking pregnant women will not receive placebo or vitamin C. |
Who may qualify
- Ages
- 15 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Randomly assigned to a study intervention at less than 22 weeks of gestation
- History of smoking
- Singleton gestation pregnancy
- Smoking cessation intervention offered but declined
Key exclusion criteria (6 listed)
- Multiple gestation pregnancy
- Documented major fetal congenital anomalies
- History of kidney stones
- Insulin dependent diabetes
- Current participation in other research projects that may interfere with this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboAlso: Sugar pillPlacebo capsule once a day | Other | A |
| Vitamin CAlso: Ascorbic acidA 500-mg vitamin C capsule once a day | Dietary supplement | B |
Primary outcome
Pulmonary function testing (including respiratory compliance and the ratio of time to peak tidal expiratory flow to total expiratory time)
Time frame: Measured within 48 hours after delivery
1 secondary outcome
Pulmonary function testing (including respiratory compliance and the ratio of time to peak tidal expiratory flow to total expiratory time)and respiratory history including wheezing through 12 months of age.
Time frame: Measured at 12 months of age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2013.
- Derived from this study: PubMed 28422514Shorey-Kendrick LE, McEvoy CT, Ferguson B, Burchard J, Park BS, Gao L, Vuylsteke BH, Milner KF, Morris CD, Spindel ER. Vitamin C Prevents Offspring DNA Methylation Changes Associated with Maternal Smoking in Pregnancy. Am J Respir Crit Care Med. 2017 Sep 15;196(6):745-755. doi: 10.1164/rccm.201610-2141OC.
- Derived from this study: PubMed 24838476McEvoy CT, Schilling D, Clay N, Jackson K, Go MD, Spitale P, Bunten C, Leiva M, Gonzales D, Hollister-Smith J, Durand M, Frei B, Buist AS, Peters D, Morris CD, Spindel ER. Vitamin C supplementation for pregnant smoking women and pulmonary function in their newborn infants: a randomized clinical trial. JAMA. 2014 May;311(20):2074-82. doi: 10.1001/jama.2014.5217.
- Derived from this study: PubMed 21159788Didenco S, Gillingham MB, Go MD, Leonard SW, Traber MG, McEvoy CT. Increased vitamin E intake is associated with higher alpha-tocopherol concentration in the maternal circulation but higher alpha-carboxyethyl hydroxychroman concentration in the fetal circulation. Am J Clin Nutr. 2011 Feb;93(2):368-73. doi: 10.3945/ajcn.110.008367. Epub 2010 Dec 15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cynthia T. McEvoy, MD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin C in people with Pregnancy and Smoking, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary function testing (including respiratory compliance and the ratio of time to peak tidal expiratory flow to total expiratory time) (time frame: Measured within 48 hours after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00632476, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2013.