Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00339521
Status:
COMPLETED
Last Update Posted:
2020-12-04
First Post:
2006-06-19
Brief Title:
Genetic Susceptibility to Childhood Respiratory IIlness in Mexico City
Sponsor:
National Institute of Environmental Health Sciences NIEHS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Genetic Susceptibility to Childhood Respiratory Illness in Mexico City
Status:
COMPLETED
Status Verified Date:
2020-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 childs 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:
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 childs 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| OH99-E-N028 | None | None | None |