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Trial record 5 of 43 for:    NIEHS and asthma

Genetic Susceptibility to Childhood Respiratory IIlness in Mexico City

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Environmental Health Sciences (NIEHS) )
ClinicalTrials.gov Identifier:
NCT00339521
First received: June 19, 2006
Last updated: January 15, 2015
Last verified: December 2014
  Purpose

We propose to add a collection of genetic material to a clinical trial of anti-oxidant supplementation for the amelioration of asthma in 7-12 year olds being conducted at a public pediatric hospital in Mexico City. The anti-oxidant study has been approved by the Institutional Review Board of the National Institute of Public Health in Mexico City and is scheduled to begin in September 1998. The purpose of this add-on study is to examine genetic polymorphisms that may be related to asthma. Asthma cases will be compared with their parents as controls. In partaicular, we will save the buffy coat from the blood collection being done on the asthmatic child for measurements of plasma micronutrients in the anti-oxidant trial for extraction of DNA. This part of the sample would otherwise be discarded. In addition, we will enroll the parents of the asthmatic child as controls for the child. From the parents, either a 10 ml blood sample or if they prefer, a sample of buccal cells will be collected. Although our current plan is to compare the asthmatic child to the parents using statistical methods based on the "transmission disequilibrium test" because research into various family designs for candidate gene studies is rapidly evolving and various sibling control sample strategies have been discussed, we would also like to collect a genetic sample on as many of the child's siblings as possible with priority given to those closest in age. This will enhance the future usefulness of the samples. We anticipate enrolling approximately 200 families.


Condition
Asthma

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Genetic Susceptibility to Childhood Respiratory Illness in Mexico City

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • To expand our enrollment of asthmatic children with high ozone exposure and parental controls (case-parent triads) to a sample size of 500 triads to create a resource to examine asthma candidate genes in Mexico City. [ Time Frame: End of Study ] [ Designated as safety issue: No ]

Estimated Enrollment: 2400
Study Start Date: October 1998
Detailed Description:

We propose to add a collection of genetic material to a clinical trial of anti-oxidant supplementation for the amelioration of asthma in 7-12 year olds being conducted at a public pediatric hospital in Mexico City. The anti-oxidant study has been approved by the Institutional Review Board of the National Institute of Public Health in Mexico City and is scheduled to begin in September 1998. The purpose of this add-on study is to examine genetic polymorphisms that may be related to asthma. Asthma cases will be compared with their parents as controls. In particular, we will save the buffy coat from the blood collection being done on the asthmatic child for measurements of plasma micronutrients in the anti-oxidant trial for extraction of DNA. This part of the sample would otherwise be discarded. In addition, we will enroll the parents of the asthmatic child as controls for the child. From the parents, either a 10 ml blood sample or if they prefer, a sample of buccal cells will be collected. Although our current plan is to compare the asthmatic child to the parents using statistical methods based on the "transmission disequilibrium test" because research into various family designs for candidate gene studies is rapidly evolving and various sibling control sample strategies have been discussed, we would also like to collect a genetic sample on as many of the child's siblings as possible with priority given to those closest in age. This will enhance the future usefulness of the samples. We anticipate enrolling approximately 200 families.

  Eligibility

Ages Eligible for Study:   4 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

Moderate to severe asthma, ages 7-12 and residing within 5 km of a particular ambient air pollution monitoring station.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00339521

Locations
Mexico
Hospital Infantil de Mexico Federico Gomez
Mexico City, Mexico
Sponsors and Collaborators
Investigators
Principal Investigator: Stephanie London, M.D. National Institute of Environmental Health Sciences (NIEHS)
  More Information

Publications:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Environmental Health Sciences (NIEHS) )
ClinicalTrials.gov Identifier: NCT00339521     History of Changes
Other Study ID Numbers: 999999028, OH99-E-N028
Study First Received: June 19, 2006
Last Updated: January 15, 2015
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Asthma
Mexico
Candidate Genes
Triads
Polymorphism

Additional relevant MeSH terms:
Genetic Predisposition to Disease
Disease Attributes
Disease Susceptibility
Pathologic Processes

ClinicalTrials.gov processed this record on February 27, 2015