Thinking Zinc: a Study of Zinc Supplements on the Navajo Nation

University of New Mexico (UNM)

Status: Enrolling

Conditions: Immune System Disorder; DNA Damage

Treatments: Drug: Zinc Picolinate 15 Mg

Study type: Interventional

Funder types: Other

Identifiers

NCT03908736

18-381

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 21 to 64 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Single-arm cohort

Other group

Description:

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.

Treatment:

Drug: Zinc Picolinate 15 Mg