Effect of the Antiandrogen DDE on Anthropometric Measures at Birth
|First Received Date ICMJE||June 19, 2006|
|Last Updated Date||December 30, 2015|
|Start Date ICMJE||May 2001|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Number of months that the mother breast feeds her baby [ Time Frame: 3 months ] [ Designated as safety issue: No ]|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00343031 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Effect of the Antiandrogen DDE on Anthropometric Measures at Birth|
|Official Title ICMJE||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 Type ICMJE||Observational|
|Study Design ICMJE||Time Perspective: Prospective|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Estimated Enrollment ICMJE||2300|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
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 ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Mexico|
|Removed Location Countries||United States|
|NCT Number ICMJE||NCT00343031|
|Other Study ID Numbers ICMJE||999901177, 01-E-N177|
|Has Data Monitoring Committee||Not Provided|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||National Institute of Environmental Health Sciences (NIEHS)|
|Study Sponsor ICMJE||National Institute of Environmental Health Sciences (NIEHS)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||December 2015|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP