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This is a study to assess the effect of dietary zinc supplementation to mitigate biomarkers of metal toxicity in exposed tribal populations.
Communities living in proximity to abandoned uranium mines have documented exposures to metals in drinking water, soil and dust. Exposure to these metals, principally uranium and arsenic, and metal mixtures is associated with dysregulation of immune function and other health effects. The objective of this study is to conduct an intervention trial to assess the effect of dietary zinc supplementation to mitigate the toxicity of metal exposures. The current project is part of a larger research effort funded by the NIH Superfund Program to study environmental metals exposures in tribal communities in New Mexico.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-arm cohort | Other | Baseline experimental measurements will be collected for each individual participant twice prior to zinc supplementation (0 month and 3 month time points). After zinc supplementation, experimental measurements will be collected for each individual participant at the 6 month and 9 month time points. The zinc intervention is zinc picolinate 15 mg once per day for 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zinc Picolinate 15 Mg | Drug | zinc picolinate, 15 mg/day for 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Metal biomonitoring to compare change from baseline versus zinc supplement | urinary and serum metal levels to be measured by inductively coupled plasma mass spectrometry | Visit 1 (0 months-baseline 1), Visit 2 (3 months-baseline 2), Visit 3 (6 months-zinc 1), Visit 4 (9 months-zinc 2) |
| Lymphocyte phenotyping to compare change from baseline versus zinc supplement | Lymphocyte phenotypes will be measured in blood samples | Visit 1 (0 months-baseline 1), Visit 2 (3 months-baseline 2), Visit 3 (6 months-zinc 1), Visit 4 (9 months-zinc 2) |
| Cytokine level measurement to compare change from baseline versus zinc supplement | A cytokine panel will be used to measure levels of multiple cytokines in blood samples | Visit 1 (0 months-baseline 1), Visit 2 (3 months-baseline 2), Visit 3 (6 months-zinc 1), Visit 4 (9 months-zinc 2) |
| Autoantibody measurement to compare change from baseline versus zinc supplement | Autoantibody panel titers will be measured in blood samples | Visit 1 (0 months-baseline 1), Visit 2 (3 months-baseline 2), Visit 3 (6 months-zinc 1), Visit 4 (9 months-zinc 2) |
| Measure | Description | Time Frame |
|---|---|---|
| DNA damage assays to compare change from baseline versus zinc supplement | DNA damage measurements in cells retrieved from blood samples | Visit 1 (0 months-baseline 1), Visit 2 (3 months-baseline 2), Visit 3 (6 months-zinc 1), Visit 4 (9 months-zinc 2) |
| PARP activity assays to compare change from baseline versus zinc supplement |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory outcome dietary nutritional intake | Food frequency questionnaire for other nutritional factors that may have impact on immune and/or DNA damage parameters | Visit 2 (3 months), Visit 4 (9 months) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laurie G Hudson, PhD | Contact | 505-272-2482 | lhudson@salud.unm.edu | |
| Debra MacKenzie, PhD | Contact | 505-272-6535 | dmackenzie@salud.unm.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of New Mexico Health Sciences Center | Recruiting | Albuquerque | New Mexico | 87131 | United States |
Individual participant data will not be shared with other researchers unless the other researchers request and receive specific permission for data from the Navajo Nation Human Research Review Board.
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| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C030614 | picolinic acid |
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This is a one-armed cohort intervention of zinc supplementation. Data will be collected for each participant before and after zinc supplementation.
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Activity measurement of the DNA repair enzyme poly (ADP ribose) polymerase (PARP) |
| Visit 1 (0 months-baseline 1), Visit 2 (3 months-baseline 2), Visit 3 (6 months-zinc 1), Visit 4 (9 months-zinc 2) |