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Effects of Tobacco Smoke Exposure on Epigenetic Signatures and Immunotoxicological Reactions

NCT01317628 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2013-10-29

No results posted yet for this study

Summary

Researchers have noted that active smoke exposure was possibly related to epigenetic mechanism,and may further influence reactive immunotoxicological reaction on human beings. Some studies have been reported that smoking reduction would decrease the prevalence of respiratory symptoms and urinary cotinine level, but the underlying epigenetic mechanism and the functional changes of immunotoxicological system were still unclear. We plan to examine the causal relationship between smoking reduction and alterations in epigenetic signatures/immunotoxicological reactions. Teenager Smoking Reduction Trial (TSRT) will be population-based trial among teenagers. Eligible teenagers will be recruited in Taipei City and urinary cotinine level will be used to monitor the exposure status of active smoking at baseline, 1-month and 3-month of the intervention process. We will assess the potential change in immunotoxicological markers, including Th1/Th2 cytokines and clinical immunological measurements, before and after the intervention program. Furthermore, whole-genome methylation and miRNA expression microarrays will be used to search candidate genes for teenager smoking exposure. We plan to develop a prediction model for immunotoxicological reaction by utilizing epigenetic signature data from microRNA expression and DNA methylation profiles based on machine learning methodologies. We will also establish a personalized epigenetic prediction model for allergy development and build the risk assessment platform for immunotoxicological reaction under tobacco smoke exposure. Finally, we will examine the causal relationship between epigenetic signatures and immunotoxicological reactions under an independent children's cohort.

Conditions

  • The Study Focused on Reducing Tobacco Smoke Exposure for Child.

Interventions

BEHAVIORAL

Tobacco smoke reduction trial intervention program

Both the parents and children will receive 8 times intervention program weekly in first session. The telephone counseling will reduce the child's tobacco smoke exposure every weekly in second session. The interventionist and child jointly select behavioral goals for reducing tobacco smoke exposure for the child to work toward. The goals will be formalized as a written smoke exposure reduction plan for any of four specific behaviors, as relevant to that family: (a) smoking cessation for the child, (b) making the child's primary home smoke-free, (c) making non-home locations smoke-free.

Sponsors & Collaborators

  • National Taiwan University Hospital

    lead OTHER

Principal Investigators

  • Yungling Lee, Ph.D · National Taiwan University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2011-06-30
Completion
2011-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01317628 on ClinicalTrials.gov