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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00043238
Other study ID # 10904-CP-001
Secondary ID
Status Completed
Phase N/A
First received August 7, 2002
Last updated April 13, 2015
Est. completion date July 2005

Study information

Verified date April 2015
Source National Institute of Environmental Health Sciences (NIEHS)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 220
Est. completion date July 2005
Est. primary completion date July 2005
Accepts healthy volunteers No
Gender Both
Age group 17 Years to 18 Years
Eligibility Participation in previous study of Mohawk adolescent well-being is required for participation in this project.

Study Design

N/A


Related Conditions & MeSH terms


Locations

Country Name City State
United States First Environments Research Project Office Akwesasne New York

Sponsors (1)

Lead Sponsor Collaborator
National Institute of Environmental Health Sciences (NIEHS)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 3:833-40. — View Citation

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