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

Thinking Zinc: A Study of Zinc Supplementation to Ameliorate Adverse Effects of Mine Waste Exposure on the Navajo Nation

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

Study Overview

• Status: Recruiting
• Conditions: DNA Damage; Immune System Disorder
• Intervention / Treatment: Drug: Zinc Picolinate 15 Mg

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Laurie G Hudson, PhD; Phone Number: 505-272-2482; Email: lhudson@salud.unm.edu
• Study Contact Backup: Name: Debra MacKenzie, PhD; Phone Number: 505-272-6535; Email: DMacKenzie@salud.unm.edu

Study Locations

• United States
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • Recruiting
      • University of New Mexico Health Sciences Center
      • Contact: Laurie G Hudson, PhD; Phone Number: 505-272-2482; Email: lhudson@salud.unm.edu
      • Contact: Debra MacKenzie, PhD; Phone Number: 505-272-6535; Email: DMacKenzie@salud.unm.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Drug: Zinc Picolinate 15 Mg; zinc picolinate, 15 mg/day for 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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	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)

Other Outcome Measures

Outcome Measure	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)

Collaborators and Investigators

• Sponsor: University of New Mexico

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2019
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: April 1, 2019
• First Submitted That Met QC Criteria: April 5, 2019
• First Posted (Actual): April 9, 2019

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Molecular Mechanisms of Pharmacological Action; Chelating Agents; Sequestering Agents; Iron Chelating Agents; picolinic acid
• Other Study ID Numbers: 18-381

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No