VCSIP Follow-up Study

Asthma Clinical Trial

— VCSIPRenewal  

Official title:

Vitamin C to Decrease the Effects of Smoking in Pregnancy on Infant Lung Function (VCSIP): Follow-up of a Randomized Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03203603
• Other study ID #: VCSIP-Renewal
• Status: Recruiting
• Start date: March 27, 2017
• Est. completion date: October 31, 2024

Study information

• Verified date: April 2024
• Source: Oregon Health and Science University
• Contact: Cindy McEvoy, MD, MCR
• Phone: 503-494-0085
• Email: mcevoyc[@]ohsu.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The overall aims of this protocol are to determine whether prenatal supplementation with vitamin C to pregnant smokers can improve pulmonary function and decrease wheeze at 5 years of age in their offspring. This is a continuation of the VCSIP trial, to follow the offspring through 5 years of age. The hypothesis for this protocol is an extension of the VCSIP trial that supplemental vitamin C in pregnant smokers can significantly improve their children's PFTs and decrease the incidence of wheeze.

Description:

The overall aims of this protocol are to determine whether prenatal supplementation with vitamin C to pregnant smokers can improve pulmonary function and decrease wheeze at 5 years of age in their offspring. This is a continuation of the VCSIP trial, to follow the offspring through 5 years of age. The hypothesis for this protocol is an extension of the VCSIP trial that supplemental vitamin C in pregnant smokers can significantly improve their children's PFTs and decrease the incidence of wheeze. The reasons for this protocol are to follow the children born to mothers randomized in the VCSIP to the age of 5 to differentiate the patients with transient versus recurrent wheeze (and therefore more likely to develop asthma); to determine if early protective effects of vitamin C are sustained to this older age; and to continue to collect biologic samples from the children for future mechanistic studies of vitamin C action. The primary aim of this study is to demonstrate improved pulmonary function at 5 years of age in the offspring of pregnant smokers randomized to vitamin C (500 mg/day) versus placebo. The investigators hypothesize that vitamin C supplementation in pregnancy will block the adverse effects of maternal smoking on offspring pulmonary function measured at 5 years of age by spirometry. Impulse oscillometry (IOS) will also be used at 3-5 years of age to assess pulmonary function. Specific Aim 2 (Secondary Outcome): The secondary aim of this study is to demonstrate a decreased incidence of wheeze at 5 years of age in offspring of pregnant smokers randomized to vitamin C (500 mg/day) versus placebo. The investigators hypothesize that vitamin C supplementation during pregnancy will decrease the incidence of wheeze at 5 years of age in offspring of smokers. Respiratory health will be assessed by quarterly validated respiratory questionnaires and clinician report.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: October 31, 2024
• Est. primary completion date: December 31, 2021
• Gender: All
• Age group: 6 Months to 4 Years

Eligibility

Inclusion Criteria:

• Women and their offspring randomized to vitamin C versus placebo during pregnancy as well as pregnant nonsmokers and their offspring enrolled as the reference group in the current RCT.

Exclusion Criteria:

• Patients specifically withdrawing consent.

Related Conditions & MeSH terms

• Asthma
• In Utero Nicotine
• Pulmonary Function
• Respiratory Sounds
• Wheezing

Intervention

Other:
• No active intervention
This is a follow-up of a randomized trial. No active intervention is being given in the follow-up.

Locations

Country	Name	City	State
United States	Indiana University	Indianapolis	Indiana
United States	Oregon Health and Science University	Portland	Oregon

Sponsors (3)

Lead Sponsor	Collaborator
Oregon Health and Science University	Indiana University, National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

McEvoy 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improved pulmonary function, spirometry	The primary aim of this study is to demonstrate improved pulmonary function at 5 years of age in the offspring of pregnant smokers randomized to vitamin C 500 mg/day versus placebo.	5 years of age
Secondary	Decreased incidence of wheeze	The secondary aim of this study is to demonstrate a decreased incidence of wheeze at 5 year of age in offspring of pregnant smokers randomized to vitamin C (500 mg/day) versus placebo	5 years of age