MDACC Study Summary 2008-0742

Study Summary
No. 2008-0742:.......Endocrine......Janice Chilton......Health Disparities Research

Study Summary Title



Study Summary Number:	2008-0742

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

Physician

New Patient Referral



Name:	Janice Chilton	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Health Disparities Research	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-563-2727 Contact us about clinical trials

General Information



Disease Group:	Endocrine	Supported By:	National Center for Minority Health and Health Disparities

Phase of Study:	N/A	Return Visit:	They will not be required to come to MDACC.

Treatment Agents:	None	Home Care:	Not applicable

Treatment Loc:	Only outside MDACC at one or more Collaborating Sites or Institutions

Estimated Length of Stay in Houston:	Not applicable


Description/ Intervention:	The goal of this research study is to learn what influence environmental chemicals, specifically phthalates, may have on the ratio of males to females born in Baytown, TX and along the rural lower Rio Grande Valley in Hidalgo County, TX.

Study Objectives / Outcomes

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.

Study Status Information



Study Activation / Registration Date:

IRB Review and Approval Date:	04/16/2009

Study Type:	Laboratory

Recruitment Status:	Closed

Projected Accrual:	300 Estimated monthly accrual: 20

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

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

Links

Registration Number: NCT00903318
Study Information on Clinical Trials Registry (clinicaltrials.gov)