Completed

NCT Number: NCT00903318

Male:Female Birth Ratios and Phthalate Levels

Objective 1: To assess environmental exposure to chemicals/toxins, including phthalates, among rural and urban Mexican American men and women (n=300), aged 18 to 40, in urban Baytown, TX and rural Rio Grande Valley (Hidalgo County) communities along the Texas-Mexico border region via survey.

Objective 2: To determine generational sex ratio trends in urban Baytown, TX and along the rural Rio Grande Valley (Hidalgo County) utilizing vital statistics data from the Texas Department of Health and the Center for Health Statistics.

Objective 3: To measure urinary phthalate levels and self-reported phthalate exposure in Mexican American men and women from urban Baytown, Texas and rural communities along the lower Rio Grande Valley (Hidalgo County) on theTexas-Mexico border. To conduct an optional procedure, chromosomal sex determination, among a subgroup of 50 persons (13 men + 12 women in each community) from participants who complete the survey in Objective 1.

Completed

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Key information

Conditions

Endocrine Diseases Endocrine System Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Goose Creek Consolidated Independent School District, Baytown, Texas, United States

About this study

Questionnaire:

If you agree to take part in this study, you will complete a questionnaire about your family's characteristics. For example, the questionnaire will have questions about your educational level, your eating habits, your health conditions, your family's income level, and how many people live in your house. The study doctor will also ask you questions about any drugs you may be taking. The questionnaire should take about 30-35 minutes to complete.

The completed paper questionnaire will be placed in a secured, locked cabinet and will be given a code number. Only the researcher in charge of the study will have access to the code numbers and be able to link the questionnaire to you. After the study ends and after information from the questionnaire has been entered in a password protected database, the paper copy of the questionnaire will be sent to M. D. Anderson to be stored for up to 5 years. After 5 years, it will be destroyed.

Urine Sample:

You will have a urine sample collected. Researchers will study the urine samples to learn what your level of exposure may be to certain chemicals in the environment, specifically chemicals called phthalates. Phthalate is the only chemical that will be measured.

Additional Information:

All information collected during this study will be kept strictly confidential, and will not contain any personal identifiable information such as your name, address, and/or telephone number. All the information will be will be given a code number. To protect confidentiality, DNA data will not be linked to participant identifiers. Only the researcher in charge of the study will have access to the code numbers and be able to link any information to you. All samples and DNA data will be destroyed within three years after the conclusion of the study.

Length of Study:

After the questionnaire is complete and the urine sample has been collected, your participation on this study will be over.

This is an investigational study. Up to 300 participants (150 from Baytown,TX and 150 from the rural lower Rio Grande Valley in Hidalgo County, TX) will take part in this study. All will be enrolled through M. D. Anderson.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Men and Women of Mexican American origin ages 18 to 40 years
Residing in Baytown or the lower Rio Grande Valley in Hidalgo County, Texas
Who have signed the informed consent
Individuals will have had to reside in the study area for at least 5 years
Pregnant women are eligible for the study.

Exclusion criteria

None

Treatment and study plan

Questionnaire

Behavioral

Questionnaire about family's characteristics taking about 30-35 minutes to complete.

Other names: Survey

Primary outcomes

Prevalence of exposure to chemical/toxins (Survey Responses)

Time frame: 3 Years

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study title

Male:Female Birth Ratios and Phthalate Levels Along The Rural Lower Rio Grande Valley (Hidalgo County) and in Baytown, Texas

Important dates

Study start: 2009
Primary completion: 2017
Study completion: 2017
First posted: May 18, 2009
Registry last updated: Feb 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed