NCT00339521

Brief 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....

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,362

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 1999

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 1999

Completed
7.1 years until next milestone

First Submitted

Initial submission to the registry

June 19, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 21, 2006

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2007

Completed
13.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2020

Completed
Last Updated

December 4, 2020

Status Verified

December 1, 2020

Enrollment Period

7.8 years

First QC Date

June 19, 2006

Last Update Submit

December 3, 2020

Conditions

Keywords

AsthmaMexicoTriadsPolymorphismGenetic Predisposition

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Case-Parent Triad

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

Eligibility Criteria

Age4 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Asthmatic children registered at the allergy clinic of the Pediatric Hospital Frederico Gomez in Mexico City and their biological parents.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Infantil de Mexico Federico Gomez

Mexico City, Mexico

Location

Related Publications (3)

  • 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.

    PMID: 8665031BACKGROUND
  • 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.

    PMID: 9522789BACKGROUND
  • 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.

    PMID: 9351593BACKGROUND

MeSH Terms

Conditions

AsthmaGenetic Predisposition to Disease

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesDisease SusceptibilityDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Stephanie London, M.D.

    National Institute of Environmental Health Sciences (NIEHS)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
CROSS SECTIONAL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2006

First Posted

June 21, 2006

Study Start

May 15, 1999

Primary Completion

February 12, 2007

Study Completion

December 3, 2020

Last Updated

December 4, 2020

Record last verified: 2020-12

Locations