Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00011388
Status:
COMPLETED
Last Update Posted:
2006-03-23
First Post:
2001-02-16
Brief Title:
Reproductive Effects of Pesticide PCB and Mercury Exposure in Laotian Immigrants
Sponsor:
National Institute of Environmental Health Sciences NIEHS
Organization:
National Institute of Environmental Health Sciences NIEHS
Study Overview
Official Title:
Organochlorine Compounds and Menstrual Cycle Function
Status:
COMPLETED
Status Verified Date:
2006-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This project is examining the reproductive effects of exposure to certain compounds that are suspected to act on the endocrine system eg they may act like or interfere with hormones such as estrogen The study is being conducted among Laotian women as it is suspected that they may have higher exposures to the compounds of interest pesticides and PCBs from their homeland and from consumption of fish caught in the San Francisco Bay Fifty Laotian immigrants were recruited by community workers to collect urine daily during 3 menstrual cycles for measurement of steroid hormones estrogen and progesterone Additionally they provided a blood sample to measure exposure levels and completed 2 interviews in their native language These measured levels as well as the self-reported data on a number of factors including fish consumption will be examined for possible effects on hormone levels and menstrual function
Detailed Description:
We are conducting a study to examine whether women who have been exposed to chlorinated pesticides or PCBs have alterations in their ovarian function as measured by the frequency of menstrual cycle disturbances Such disturbances may impact the frequency of infertility and sub-fertility as well as that of other hormone-dependent illnesses such as breast cancer and osteoporosis The target population is a group of Laotian immigrants who are frequent consumers of fish caught locally in the San Francisco Bay Contaminant levels above health protective advisories have been documented in Bay fish and shellfish for a number of these substances Immigration from Asia as well as consumption of contaminated fish have been shown to be associated with higher organochlorine pesticide body burdens Exposure is determined by measuring serum levels of a panel of pesticide metabolites including those of DDT chlordane hepatochlor and others as well as PCB congeners In addition mercury levels are measured in the blood Menstrual function is assessed by measuring urinary metabolites of steroid hormones daily during three menstrual cycles of 50 Laotian women of reproductive age The participants were also asked to complete two detailed in-person interviews about various factors including fish consumption
We previously conducted a study of menstrual function in a group of 400 women during which we developed algorithms to determine ovulatory status day of ovulation and menstrual cycle disturbances such as short luteal phase that can also be applied to the new sample This previously collected sample or the Asians therein will serve as a baseline comparison group for the current sample In addition it will provide a source of data on the effects of lifestyle such as smoking and alcohol consumption and demographic such as age and ethnicity factors on menstrual function allowing for more efficient examination of a small group of exposed women in the current study In addition to serum organochlorine levels questionnaire measures of exposure eg species-specific fish consumption occupational exposure and previous residence will be examined in relation to ovarian function defined as continuous measures eg cycle length steroid conjugate levels and dichotomous abnormalities eg short luteal phase or anovulation At this time all data collection is complete hormones measured and analyses begun
In working with this refugee lower socioeconomic status community we adopted a model of participatory research Steps were taken to develop partnerships with various community organizations Staff who spoke one of the three prominent dialects Mien Lao or Khmu were hired from the local community and provided with training to present information about reproductive and environmental health to the community Participants were compensated for their time as well as being provided with educational materials about reproductive health safe consumption of seafood and their own results
We previously conducted a study of menstrual function in a group of 400 women during which we developed algorithms to determine ovulatory status day of ovulation and menstrual cycle disturbances such as short luteal phase that can also be applied to the new sample This previously collected sample or the Asians therein will serve as a baseline comparison group for the current sample In addition it will provide a source of data on the effects of lifestyle such as smoking and alcohol consumption and demographic such as age and ethnicity factors on menstrual function allowing for more efficient examination of a small group of exposed women in the current study In addition to serum organochlorine levels questionnaire measures of exposure eg species-specific fish consumption occupational exposure and previous residence will be examined in relation to ovarian function defined as continuous measures eg cycle length steroid conjugate levels and dichotomous abnormalities eg short luteal phase or anovulation At this time all data collection is complete hormones measured and analyses begun
In working with this refugee lower socioeconomic status community we adopted a model of participatory research Steps were taken to develop partnerships with various community organizations Staff who spoke one of the three prominent dialects Mien Lao or Khmu were hired from the local community and provided with training to present information about reproductive and environmental health to the community Participants were compensated for their time as well as being provided with educational materials about reproductive health safe consumption of seafood and their own results
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None