Genetic Susceptibility to Childhood Respiratory IIlness in Mexico City

Asthma Clinical Trial

Official title:

Genetic Susceptibility to Childhood Respiratory Illness in Mexico City

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00339521
• Other study ID #: 999999028
• Secondary ID: OH99-E-N028
• Status: Completed
• Start date: May 15, 1999
• Est. completion date: December 3, 2020

Study information

• Verified date: December 2020
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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....

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2362
• Est. completion date: December 3, 2020
• Est. primary completion date: February 12, 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 17 Years

Eligibility

• INCLUSION CRITERIA:

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

Related Conditions & MeSH terms

• Asthma
• Genetic Predisposition to Disease

Locations

Country	Name	City	State
Mexico	Hospital Infantil de Mexico Federico Gomez	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Environmental Health Sciences (NIEHS)

Country where clinical trial is conducted

Mexico, 

References & Publications (3)

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. — View Citation

Sandford A, Weir T, Paré P. The genetics of asthma. Am J Respir Crit Care Med. 1996 Jun;153(6 Pt 1):1749-65. Review. — View Citation

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. Erratum in: Am J Respir Crit Care Med 1998 Feb;157(2):671. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To create a resource to examine genetic susceptibility to asthma in Mexico City.	The role of asthma candidate genes in the association between ozone exposure and asthma incidence.	End of Study