Effect of the Antiandrogen DDE on Anthropometric Measures at Birth
|ClinicalTrials.gov Identifier: NCT00343031|
Recruitment Status : Completed
First Posted : June 21, 2006
Last Update Posted : April 5, 2018
|First Submitted Date||June 19, 2006|
|First Posted Date||June 21, 2006|
|Last Update Posted Date||April 5, 2018|
|Study Start Date||May 14, 2001|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures
||Number of months that the mother breast feeds her baby [ Time Frame: 3 months ]|
|Original Primary Outcome Measures||Not Provided|
|Change History||Complete list of historical versions of study NCT00343031 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures||Not Provided|
|Original Secondary Outcome Measures||Not Provided|
|Current Other Outcome Measures||Not Provided|
|Original Other Outcome Measures||Not Provided|
|Brief Title||Effect of the Antiandrogen DDE on Anthropometric Measures at Birth|
|Official Title||Effect of the Antiandrogen DDE on Anthropometric Measures at Birth|
Experimental studies have documented the p'p-DDT, p'p-DDE (a metabolite of DDT) and other organochlorine (OC) compounds have estrogenic and/or antiandrogenic activities capable of altering normal endocrine functions. It has been postulated that exposure to these toxins during embriogenesis may cause urogenital malformations. However, this hypothesis has not yet been evaluated in humans populations with relatively high levels of exposure. The primary goal of this project is to study in utero exposure to DDE in relation to anogenital distance in humans. Anogenital distance is measured from a gender and species specific landmark on the genitalia, such as the junction of the penis and the scrotum in male humans, to the center of the anus. Altered anogenital distance is a sensitive manifestation of prenatal endocrine disruption in animal models; whether it is a sensitive endpoint in humans has not been studied. We will test the hypothesis that DDE, an androgen-receptor blocker, decreases anogenital distance in male humans who have been chronically but not occupationally exposed to DDT in Mexico. Study participants will be newborns and their mothers who live in the state of Chiapas, Mexico and who have been exposed to DDT through house spraying programs to control malaria in this area. Anogenital distance will be measured at birth and in utero exposure to DDE will be determined by measuring DDE in maternal blood.
Demonstration that p'p-DDT or p'p-DDE may interfere with normal endocrine functions during embriogenesis will provide a model to increase our understanding of how other- more prevalent-environmental estrogens may act and will open new possibilities for research and potential control of etiologic factors related with this important public health problem.
We propose to follow the women and children enrolled in our original study (n= approximately 850 of each). In the original study, women were enrolled and interviewed while in the hospital for delivery, their blood was drawn, and anthropometric measurements were performed on their newborn male infants.
The follow-up will be done primarily to determine the number of months that the mother breast feeds her child. Secondary endpoints will be infant infection as reported by the mother, and child growth as determined by measurement of height and weight and related measures (none in the genital region, as in the original study). Breast feeding duration, infections, and growth may be related to exposure to the DDT metabolite, DDE.
The follow-up visits will be every three months from 6 to 18 months after birth, and study nurses will visit subjects in their home. For some subjects, there would be fewer follow-up visits, due to study scheduling or breastfeeding cessation.
Mothers would be interviewed and mothers and children will undergo standard anthropometric assessments. This protocol does not call for collection of biologic specimens and poses minimal risk to subjects.
|Study Design||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Study Groups/Cohorts||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Study Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
Pregnant women delivering male infants in Tapachula and surrounding areas.
Women must not be over 35 years of age.
A physician's diagnosis of multiple fetuses, pre-eclampsia or pregnancy-related hypertension disorders or psychiatric, kidney, or cardiac disease; gestational diabetes; history of repeated urinary infections; seizure disorder requiring daily medications; ingestion of corticosteroids, and non-Spanish speakers.
At time of birth, additional exclusion criteria will include: an Apgar score (at five minutes) of 6 or less; any condition requiring treatment in the neonatal intensive care unit.
Infants must not have any condition requiring treatment in the neonatal intensive care unit.
|Ages||up to 20 Years (Child, Adult)|
|Accepts Healthy Volunteers||No|
|Contacts||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries||Mexico|
|Removed Location Countries||United States|
|Other Study ID Numbers||999901177
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||National Institutes of Health Clinical Center (CC) ( National Institute of Environmental Health Sciences (NIEHS) )|
|Study Sponsor||National Institute of Environmental Health Sciences (NIEHS)|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||December 4, 2017|