NCT00340301

Brief Summary

Chemicals called neurotoxins can harm the nervous system. Amyotrophic lateral sclerosis (ALS) is a progressive disease affecting movement. Researchers have studied many possible causes of ALS, including injury, diet, and exposure to chemicals, but these studies were inconclusive. The purpose of this study was to determine whether exposure to lead or other neurotoxins can contribute to ALS. The study also evaluated lifestyle and dietary patterns. The study was completed in 1994-1996. One hundred eighty-two participants took part in this study 110 patients with ALS and 72 who did not have ALS. Each completed a questionnaire concerning lifestyle, diet, and residential, job, and medical history. Participants contributed 50 cc of blood, used to measure lead, as well as clippings of their toenails, used to measure mercury and other metals. They then underwent an XRF test (an X-ray procedure) to measure the level of lead in their shinbones and knees. Genes related to ALS or susceptibility to lead exposure were also evaluated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
397

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2003

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

June 3, 2003

Completed
3 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
12.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 23, 2019

Completed
Last Updated

January 25, 2019

Status Verified

January 23, 2019

First QC Date

June 19, 2006

Last Update Submit

January 24, 2019

Conditions

ALS

Keywords

PolymorphismNeurodegenerative DiseasesALS

Outcome Measures

Primary Outcomes (1)

  • Measurement in blood or toenails of genes, proteins, neurotoxicants, and other factors or agents potentially associated with ALS

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

  • Potential controls were excluded if they had a physician diagnosis of a neurodegenerative disease, polio, post-polio syndrome, or nondiabetic neuropathy.
  • Pregnant women were excluded from both case and control groups.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New England Medical Center

Boston, Massachusetts, 02111, United States

Location

Related Publications (3)

  • Nelson LM. Epidemiology of ALS. Clin Neurosci. 1995-1996;3(6):327-31.

    PMID: 9021253BACKGROUND

  • Shaw PJ. Motor neurone disease. BMJ. 1999 Apr 24;318(7191):1118-21. doi: 10.1136/bmj.318.7191.1118. No abstract available.

    PMID: 10213726BACKGROUND

  • Mitchell JD. Amyotrophic lateral sclerosis: toxins and environment. Amyotroph Lateral Scler Other Motor Neuron Disord. 2000 Sep;1(4):235-50. doi: 10.1080/14660820050515061.

    PMID: 11465017BACKGROUND

MeSH Terms

Conditions

Neurodegenerative Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases

Study Officials

  • Freya Kamel, Ph.D.

    National Institute of Environmental Health Sciences (NIEHS)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2006

First Posted

June 21, 2006

Study Start

June 3, 2003

Study Completion

January 23, 2019

Last Updated

January 25, 2019

Record last verified: 2019-01-23

Locations

US(1)