Clinical trial NCT00903318: Male:Female Birth Ratios and Phthalate Levels
Official title: Male:Female Birth Ratios and Phthalate Levels Along The Rural Lower Rio Grande Valley (Hidalgo County) and in Baytown, Texas
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endocrine Diseases
Keywords: Endocrine
Environmental Chemicals
Male:Female Birth Ratio
Phthalate Exposure
Generational sex ratio trends
Mexican American
Baytown
Rio Grande Valley
Hidalgo County
Texas
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2009-05-18
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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 for at least 45 years.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1) None

Primary outcomes:
measure: Prevalence of exposure to chemical/toxins (Survey Responses)
timeFrame: 3 Years
Secondary outcomes:
Other outcomes:
Locations:
city: Baytown
country: United States
facility: Goose Creek Consolidated Independent School District
state: Texas
city: Houston
country: United States
facility: Texas Southern University
state: Texas
city: La Joya
country: United States
facility: LaJoya Independent School District
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Richard A. Hajek, PHD, MS, BA
role: PRINCIPAL_INVESTIGATOR
References: