Clinical trial NCT03908736: Thinking Zinc: a Study of Zinc Supplements on the Navajo Nation
Official title: Thinking Zinc: A Study of Zinc Supplementation to Ameliorate Adverse Effects of Mine Waste Exposure on the Navajo Nation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: DNA Damage
Immune System Disorder
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2019-04-09
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a one-armed cohort intervention of zinc supplementation. Data will be collected for each participant before and after zinc supplementation.
Primary purpose: BASIC_SCIENCE

Brief summary: This is a study to assess the effect of dietary zinc supplementation to mitigate biomarkers of metal toxicity in exposed tribal populations.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Men or women between the ages of 21 and 64 years of age
* Lives in or near the participating communities of Blue Gap-Tachee Arizona or Red Water Pond Road Community New Mexico
* Willing to provide blood and urine samples
* Willing to attend study visits on scheduled dates
* Willing to take a daily zinc supplement

Exclusion Criteria:

* Women who are pregnant or nursing or women who plan to become pregnant during the course of the study.
* Individuals who have self-reported diabetes, report that they are undergoing treatment for diabetes, or are currently taking medication for diabetes.
* Known or suspected allergy to zinc.
* Individuals previously diagnosed with syndromes of copper homeostasis (Menkes disease or Wilsons disease).
* Individuals consuming zinc supplements or multivitamins and are unwilling to stop for the duration of the study.

Primary outcomes:
measure: Metal biomonitoring to compare change from baseline versus zinc supplement
timeFrame: 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: Lymphocyte phenotyping to compare change from baseline versus zinc supplement
timeFrame: 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: Cytokine level measurement to compare change from baseline versus zinc supplement
timeFrame: 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: Autoantibody measurement to compare change from baseline versus zinc supplement
timeFrame: Visit 1 (0 months-baseline 1), Visit 2 (3 months-baseline 2), Visit 3 (6 months-zinc 1), Visit 4 (9 months-zinc 2)
Secondary outcomes:
measure: DNA damage assays to compare change from baseline versus zinc supplement
timeFrame: 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: PARP activity assays to compare change from baseline versus zinc supplement
timeFrame: Visit 1 (0 months-baseline 1), Visit 2 (3 months-baseline 2), Visit 3 (6 months-zinc 1), Visit 4 (9 months-zinc 2)
Other outcomes:
measure: Exploratory outcome dietary nutritional intake
timeFrame: Visit 2 (3 months), Visit 4 (9 months)
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico Health Sciences Center
state: New Mexico
Study officials:
References: