Exposure to Neurotoxins as Risk Factors for Amyotrophic Lateral Sclerosis
Primary Purpose
Amyotrophic Lateral Sclerosis, ALS
Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Amyotrophic Lateral Sclerosis focused on measuring Case-Control Study, Death Certificates, National Death Index, Cause of Death Information, Lead Exposure, Amyotrophic Lateral Sclerosis, ALS
Eligibility Criteria
INCLUSION CRITERIA: The purpose of the NDI search will be to verify death and obtain date and cause of death information for the study participants.
Sites / Locations
- NIEHS, Research Triangle Park
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00339976
First Posted
June 19, 2006
Last Updated
June 30, 2017
Sponsor
National Institute of Environmental Health Sciences (NIEHS)
1. Study Identification
Unique Protocol Identification Number
NCT00339976
Brief Title
Exposure to Neurotoxins as Risk Factors for Amyotrophic Lateral Sclerosis
Official Title
Ascertainment of Death in ALS Patients
Study Type
Observational
2. Study Status
Record Verification Date
April 21, 2008
Overall Recruitment Status
Completed
Study Start Date
August 6, 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 21, 2008 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute of Environmental Health Sciences (NIEHS)
4. Oversight
5. Study Description
Brief Summary
This study is a follow-up to an earlier study that examined the relationship of This study will examine whether exposure to neurotoxins, such as lead, mercury, solvents, and pesticides, can contribute to amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease. The cause of this degenerative disease of the brain and spinal cord is not well understood. Some studies suggest that exposure to environmental neurotoxins may increase its risk. This follow-up study will examine the relationship of neurotoxin exposure to the interval between the diagnosis of ALS and death. It will also examine the possible roles of genetics, lifestyle and dietary factors in the disease. Information on ALS patients previously enrolled in the study will be used to examine this relationship. No new individuals will be enrolled in the study.
Detailed Description
Objective: The objective of this proposal is linkage with the National Death Index (NDI) for cases from a study that was conducted in the early 1990's. The purpose of the initial study was to examine the role that lead and other exposures, including mercury and solvents, play in the etiology of amyotrophic lateral sclerosis (ALS).
Study population: The study involved 110 ALS cases and 256 population based controls, recruited in New England between 1993 and 1996. Data collection involved an interview, blood collection, and measurement of bone lead using x-ray fluorescence.
Design and outcome parameters: The results of this study suggested that lead exposure was a risk factor for ALS. Compared to controls, cases were more likely to have occupational lead exposure, and both blood and bone lead levels were higher in cases. We are presently analyzing data on other neurotoxic exposures including mercury, solvents, and pesticides. In order to investigate prognosis, we would like to determine the date of death by searching the National Death Index. This information will enable us to evaluate the relationship of neurotoxic exposures to ALS prognosis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis, ALS
Keywords
Case-Control Study, Death Certificates, National Death Index, Cause of Death Information, Lead Exposure, Amyotrophic Lateral Sclerosis, ALS
7. Study Design
Enrollment
0 (false)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA:
The purpose of the NDI search will be to verify death and obtain date and cause of death information for the study participants.
Facility Information:
Facility Name
NIEHS, Research Triangle Park
City
Research Triangle Park
State/Province
North Carolina
ZIP/Postal Code
27709
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
6683374
Citation
Bharucha NE, Schoenberg BS, Raven RH, Pickle LW, Byar DP, Mason TJ. Geographic distribution of motor neuron disease and correlation with possible etiologic factors. Neurology. 1983 Jul;33(7):911-5. doi: 10.1212/wnl.33.7.911.
Results Reference
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Exposure to Neurotoxins as Risk Factors for Amyotrophic Lateral Sclerosis
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