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Genetic Susceptibility to Childhood Respiratory IIlness in Mexico City

NCT ID: NCT00339521

Last Updated: 2020-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2362 participants

Study Classification

OBSERVATIONAL

Study Start Date

1999-05-15

Study Completion Date

2020-12-03

Brief Summary

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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....

Detailed Description

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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.

Conditions

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Asthma

Keywords

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Asthma Mexico Triads Polymorphism Genetic Predisposition

Study Design

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Observational Model Type

FAMILY_BASED

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Case-Parent Triad

Childhood Asthmatics (aged 4-17) are Cases; biologic parents of cases are genetic Controls.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

4 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Environmental Health Sciences (NIEHS)

NIH

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stephanie London, M.D.

Role: PRINCIPAL_INVESTIGATOR

National Institute of Environmental Health Sciences (NIEHS)

Locations

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Hospital Infantil de Mexico Federico Gomez

Mexico City, , Mexico

Site Status

Countries

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United States Mexico

References

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Sandford A, Weir T, Pare P. The genetics of asthma. Am J Respir Crit Care Med. 1996 Jun;153(6 Pt 1):1749-65. doi: 10.1164/ajrccm.153.6.8665031.

Reference Type BACKGROUND
PMID: 8665031 (View on PubMed)

Hopes E, McDougall C, Christie G, Dewar J, Wheatley A, Hall IP, Helms PJ. Association of glutamine 27 polymorphism of beta 2 adrenoceptor with reported childhood asthma: population based study. BMJ. 1998 Feb 28;316(7132):664. doi: 10.1136/bmj.316.7132.664. No abstract available.

Reference Type BACKGROUND
PMID: 9522789 (View on PubMed)

Slutsky AS, Zamel N. Genetics of asthma: the University of Toronto Program. University of Toronto Genetics of Asthma Research Group. Am J Respir Crit Care Med. 1997 Oct;156(4 Pt 2):S130-2. doi: 10.1164/ajrccm.156.4.12tac-10.

Reference Type BACKGROUND
PMID: 9351593 (View on PubMed)

Other Identifiers

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OH99-E-N028

Identifier Type: -

Identifier Source: secondary_id

999999028

Identifier Type: -

Identifier Source: org_study_id