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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-19

Study Completion Date

2027-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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DNA Damage Immune System Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This is a one-armed cohort intervention of zinc supplementation. Data will be collected for each participant before and after zinc supplementation.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Single-arm cohort

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.

Group Type OTHER

Zinc Picolinate 15 Mg

Intervention Type DRUG

zinc picolinate, 15 mg/day for 6 months

Interventions

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Zinc Picolinate 15 Mg

zinc picolinate, 15 mg/day for 6 months

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes