Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00011388 |
| Other study ID # |
8324-CP-001 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
February 16, 2001 |
| Last updated |
March 22, 2006 |
Study information
| Verified date |
March 2006 |
| Source |
National Institute of Environmental Health Sciences (NIEHS) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
United States: Federal Government |
| Study type |
Observational
|
Clinical Trial Summary
This project is examining the reproductive effects of exposure to certain compounds that are
suspected to act on the endocrine system, e.g. 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.
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 (e.g. species-specific fish consumption, occupational
exposure and previous residence) will be examined in relation to ovarian function defined as
continuous measures (e.g. cycle length, steroid conjugate levels) and dichotomous
abnormalities (e.g. 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.
