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

Not Applicable

Recruiting

• Conditions: DNA Damage; Immune System Disorder
• Interventions: Drug: Zinc Picolinate 15 Mg

• Registration Number: NCT03908736
• Lead Sponsor: University of New Mexico

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.

Study Timeline

• Study First Submitted: 2019-04-01
• Study First Submitted QC: 2019-04-05
• Study First Posted: 2019-04-09
• Study Start: 2019-05-19
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-20
• Primary Completion: 2027-07
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single-arm cohort	Zinc Picolinate 15 Mg	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.

Primary Outcome Measures

Name	Time	Method
Metal biomonitoring to compare change from baseline versus zinc supplement	Visit 1 (0 months-baseline 1), Visit 2 (3 months-baseline 2), Visit 3 (6 months-zinc 1), Visit 4 (9 months-zinc 2)	urinary and serum metal levels to be measured by inductively coupled plasma mass spectrometry
Lymphocyte phenotyping to compare change from baseline versus zinc supplement	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 phenotypes will be measured in blood samples
Cytokine level measurement to compare change from baseline versus zinc supplement	Visit 1 (0 months-baseline 1), Visit 2 (3 months-baseline 2), Visit 3 (6 months-zinc 1), Visit 4 (9 months-zinc 2)	A cytokine panel will be used to measure levels of multiple cytokines in blood samples
Autoantibody measurement to compare change from baseline versus zinc supplement	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 panel titers will be measured in blood samples

Secondary Outcome Measures

Name	Time	Method
DNA damage assays to compare change from baseline versus zinc supplement	Visit 1 (0 months-baseline 1), Visit 2 (3 months-baseline 2), Visit 3 (6 months-zinc 1), Visit 4 (9 months-zinc 2)	DNA damage measurements in cells retrieved from blood samples
PARP activity assays to compare change from baseline versus zinc supplement	Visit 1 (0 months-baseline 1), Visit 2 (3 months-baseline 2), Visit 3 (6 months-zinc 1), Visit 4 (9 months-zinc 2)	Activity measurement of the DNA repair enzyme poly (ADP ribose) polymerase (PARP)

Trial Locations

Locations (1)

University of New Mexico Health Sciences Center; 🇺🇸 Albuquerque, New Mexico, United States