Thyroid DiseasesNCT00043238
Mohawk Culture, Behavior, Toxicant Exposure and Health
An observational study of Thyroid Diseases and Cognition Disorders, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.
Trial summary
This study will determine the pathways between Mohawk cultural identification and specific behaviors related to pollutant exposure, and determine the effects of these factors and the pollutant exposure on physiologically and socially significant outcomes. Read more about this study
- Who is it for?
- Ages 17 to 18 years
- Conditions the study is for
- Thyroid Diseases, Cognition Disorders
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Jul 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Participation in previous study of Mohawk adolescent well-being is required for participation in this project.
Trial locations and contacts
1 site in 1 country.
United States1 site
First Environments Research Project Office
Hogansburg, New York, 13655
About this study
This study will determine the pathways between Mohawk cultural identification and specific behaviors related to pollutant exposure, and determine the effects of these factors and the pollutant exposure on physiologically and socially significant outcomes.
Read the detailed description
Considerable concern now exists over possible effects on human physical and psychological development of endocrine disrupting environmental contaminants such as polychlorinated biphenyls (PCBs). Native American communities are particularly at risk owing to subsistence systems and a cultural ethos involving greater contact with the physical environment. The proposed study follows-up 220 Mohawk adolescents aged 17-21 years, who participated in a previous study when they were 10-16 years old. All adolescents are members of the Mohawk Nation at Akwesasne which is located on the St. Lawrence River and is adjacent to hazardous waste sites where PCBs have contaminated the local ecology. The investigation examines the interrelationship between Mohawk cultural identity, traditional Mohawk customs, behaviors related to toxicant exposure and current toxicant burden. Serum level of PCBs will be assessed by congener specific analysis. The study will determine the relationship of congeners and their hydroxylated metabolites to thyroid function (levels of triiodothyronine, free triiodothyronine, thyroxine, free thyroxine, thyrotropin and anti-thyroid antibodies), and 2) psychosocial outcomes including school behavior and performance, hyperactivity, and adaptation to the community. Data gathered for the past study will be employed to assess variation in metabolism of PCBs, as well as how earlier measures of cognition and hyperactivity relate to 17 year old psychosocial outcomes. Variation in susceptibility to PCB effects will be determined by examining the effects of concurrent toxicant exposure (hexachlorobenzene, Mirex, dichlorodiphenyldichloroethene, lead), diet, and indicators of PCB metabolism, on the focal measures of adult functioning. The proposed study will clarify the causal pathways between culturally identifying behavior, PCB exposure and body burden, thyroid functioning, cognitive functioning, social behavior and school functioning while identifying activities that are important to maintain cultural identify and unrelated to exposure.
- Conditions
- Thyroid Diseases, Cognition Disorders
- Keywords
- PCBs, Thyroid, Hyperactivity, School Performance, Mohawk Tribe
- Medical subject headings
- Thyroid Diseases, Cognition Disorders, Spasm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2002 (estimated)
- Primary completionJul 2005
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thyroid DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00043238
- Sponsor's protocol ID
- 10904-CP-001
- Status last verified
- Apr 2015
- First submitted
- 7 Aug 2002
- Last updated
- 14 Apr 2015
- Results posted
- No
Publications
Schell LM, Tarbell AM. A partnership study of PCBs and the health of Mohawk youth: lessons from our past and guidelines for our future. Environ Health Perspect. 1998 Jun;106 Suppl 3(Suppl 3):833-40. doi: 10.1289/ehp.98106833.
PubMed 9646046
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mohawk Culture, Behavior, Toxicant Exposure and Health
- ClinicalTrials.gov ID
- NCT00043238
- Acronym / sponsor ID
- 10904-CP-001
- Conditions
- Thyroid Diseases, Cognition Disorders
- Keywords
- PCBs, Thyroid, Hyperactivity, School Performance, Mohawk Tribe
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)US National Institutes of Health
- Primary completion
- Jul 2005 (actual)
- Study completion
- Jul 2005 (actual)
- First posted
- 8 Aug 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will determine the pathways between Mohawk cultural identification and specific behaviors related to pollutant exposure, and determine the effects of these factors and the pollutant exposure on physiologically and socially significant outcomes.
Detailed description
Considerable concern now exists over possible effects on human physical and psychological development of endocrine disrupting environmental contaminants such as polychlorinated biphenyls (PCBs). Native American communities are particularly at risk owing to subsistence systems and a cultural ethos involving greater contact with the physical environment. The proposed study follows-up 220 Mohawk adolescents aged 17-21 years, who participated in a previous study when they were 10-16 years old. All adolescents are members of the Mohawk Nation at Akwesasne which is located on the St. Lawrence River and is adjacent to hazardous waste sites where PCBs have contaminated the local ecology. The investigation examines the interrelationship between Mohawk cultural identity, traditional Mohawk customs, behaviors related to toxicant exposure and current toxicant burden. Serum level of PCBs will be assessed by congener specific analysis. The study will determine the relationship of congeners and their hydroxylated metabolites to thyroid function (levels of triiodothyronine, free triiodothyronine, thyroxine, free thyroxine, thyrotropin and anti-thyroid antibodies), and 2) psychosocial outcomes including school behavior and performance, hyperactivity, and adaptation to the community. Data gathered for the past study will be employed to assess variation in metabolism of PCBs, as well as how earlier measures of cognition and hyperactivity relate to 17 year old psychosocial outcomes. Variation in susceptibility to PCB effects will be determined by examining the effects of concurrent toxicant exposure (hexachlorobenzene, Mirex, dichlorodiphenyldichloroethene, lead), diet, and indicators of PCB metabolism, on the focal measures of adult functioning. The proposed study will clarify the causal pathways between culturally identifying behavior, PCB exposure and body burden, thyroid functioning, cognitive functioning, social behavior and school functioning while identifying activities that are important to maintain cultural identify and unrelated to exposure.
Study design
Who may qualify
- Ages
- 17 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2015.
- Background: PubMed 9646046Schell LM, Tarbell AM. A partnership study of PCBs and the health of Mohawk youth: lessons from our past and guidelines for our future. Environ Health Perspect. 1998 Jun;106 Suppl 3(Suppl 3):833-40. doi: 10.1289/ehp.98106833.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Diseases and Cognition Disorders, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00043238, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2015.