Project 2 - 2010

A. SPECIFIC AIMS
The specific aims of the study are unchanged and are as follows:

1. Aim 1 is to determine the relationship between the body burden of PCB congeners and measures of reproductive function in females, specifically: a) pituitary function as indexed by gonadotropin levels (luteinizing hormone, LH; follicle stimulating hormone, FSH), b) gonadal function as indexed by estradiol (E2) and progesterone (P) levels to characterize both i) their values in different functional phases of the cycle and, ii) the shape each cycle as whole, and c) other characteristics of the menstrual cycle as reported through diary and questionnaire. Since some PCB congeners may act as agonists and others antagonists, this specific aim is stated in general terms, although hypotheses under test will posit directional relationships between individual congeners, or groups of each, and reproductive function measures.
2. Aim 2 is to determine the relationship between lead levels and measures of reproductive function as described in aim 1 above.
3. Aim 3 is to determine whether there are moderating factors (includes susceptibility factors) that influence effects of PCBs and lead on measures of reproductive functioning. These factors include body composition, diet, lifestyle factors; socio-demographic factors; other toxicants (mirex; dichlorodiphenyl-dichloroethylene, p,p’-DDE; hexachloro-benzene, HCB); a marker of autoimmune disease (TPOAb antibody); and thyroid function (triiodothyronine, T3; thyroxine, T3; free thyroxine, fT4; free triiodothyronine, fT3; and thyrotropin, TSH); and, because, PCBs and Pb may act as modifiers of one another, their  potential interaction is distinguished from those of other modifiers.

B. STUDIES AND RESULTS
During the second grant year, considerable time and effort was focused on training of Mohawk staff in recruitment of potential participants, and data collection. In concert with this effort we concentrated on:

1. Hiring an assistant to the registered nurse to facilitate data collection. A community member that is invested in the well-being of the people of Akwesasne, she helps the RN on all participant visits with anthropometric measurements and blood draws. She is a certified phlebotomist.
2. Training the RN and her assistant in data collection techniques including conducting interviews, phlebotomy, and anthropometry, research ethics, and other data collection methods.
3. Hiring and training a replacement for the registered nurse who is on maternity leave.
4. Revising recruitment and data collection protocols in partnership with the director of the St. Regis Mohawk Health Service (SRMHS) and the nurse most familiar with the ob-gyn clinic.
a. Interviews and questionnaires that were revised according to suggestions by our Mohawk collaborators were submitted to the University at Albany’s Institutional Review Board (IRB) at the Office of Research Compliance and approved.
b. Brochures, flyers, and posters for distribution at the SRMHS and community centers were approved by the University at Albany’s Institutional Review Board (IRB) at the Office of Research Compliance.
5. Development of the database for data entry has been completed, and data entry has commenced.
6. Increasing the age range eligible to participate in the study from the original range of 21-35 years of age to 21-38 years of age. This follows the recommendation of the SRMHS clinic director who was concerned of an overly narrow age eligibility.
7. Expanding our recruitment to women who seek care from the Canadian Health Service, with permission and approval by the University at Albany IRB, the Canadian Health Services Director, and the SRMHS Director. Akwesasne women using the Canadian Health Service had heard about the project and were interested in participating.  This increases our pool of potential participants.
8. Recruitment to date:
a. As of 9/20/2010, a total of 187 women have been approached. Of these, 88 were ineligible (using birth control, pregnant, nursing, on thyroid medications, or outside age range), 36 were not interested or did not have the time, and 16 were unreachable after initial contact.
b. Forty-seven women have signed informed consent forms. Of these 47, three withdrew before completing project requirements (one became pregnant, one decided to go on birth control, and one was unable to be reached to schedule appointments), 24 have completed all requirements of the study, 8 have yet to finish their saliva collection, and 12 are waiting for their next menstrual cycle to begin and to start data collection.
c. As of 10/01/2010, there are eight (8) potential participants who are waiting to meet the eligibility criteria (Completed time post- nursing, post-birth control, post- pregnancy).
9. Results as of 10/01/2010:
a.  Toxicant levels: Of the 28 whole blood serums delivered to the Exposure Assessment Laboratory, final toxicant levels on 15 have been received and these data entered.
b.  Clinical chemistries:  Of the 35 bloods delivered to LabCorps Inc. for analysis of the clinical chemistries, results on all 35 individuals have been received.
c. Salivary estradiol and progesterone levels: Saliva collected over the course of one menstrual cycle on 26 women has been delivered to the Neurobehavioral Laboratory. Preliminary results on 26 women have been completed.
C. SIGNIFICANCE
Scientific significance cannot be assessed until more results are obtained, and this cannot occur until data collection is complete for more participants. The immediate and non-scientific significance is that the work to date shows that there is substantial interest in the research by the community, good participation from those women who are eligible, and that the protocol for data collection and laboratory analyses is workable. It also shows that the partnership between the Akwesasne Mohawk Nation and the University at Albany is on solid footing. 

D. PLANS
Our plans for the near future are as follows:
1. Continue recruiting participants. We estimate an average of three to four participants a month.
2. Continue data collection and data entry.
3. Continue meeting with the SRMHS director to discuss the project and future directions.
4. Conduct a CKON Radio (local station) interview with the PI (Schell) which will be broadcast in both English and Mohawk (translated) to discuss the project.
5. Present results to the health providers and the project participants.

E. PUBLICATIONS
Schell LM, Gallo MV. Relationships of putative endocrine disruptors to human sexual maturation and thyroid activity in youth. 2010 Physiol Behav. 99:246-253.  (See Appendix)
Schell LM, Gallo MV, Ravenscroft J. Environmental influences on human growth and development. 2009. Annals of Human Biology, 36(5):459-77. (Publication was proofed before award was made; grant number is absent.)
Schell LM, Denham M, Stark AD, Parsons P, Schulte E. 2009. Growth of infants’ length, weight, head and arm circumferences in relation to low levels of blood lead measured serially. American Journal of Human Biology. 21(2): 180-18. (Publication was proofed before award was made; grant number is absent.)
Presentations:
Burnitz KK, Schell LM, Gallo MV. Native American risk to obesity:  dietary and thyroid relationships among the Akwesasne Mohawk. Presented at the 35th Annual Meeting of the Human Biology Association. Albuquerque, NM, April 1, 2010.

F. PROJECT-GENERATED RESOURCES
None to date.