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Recruiting NCT03908736

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

Phase II Interventional DNA Damage Immune System Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Zinc Picolinate 15 Mg.
Who it may be relevant to
Registry conditions: DNA Damage, Immune System Disorder. Basic parameters: 21 years — 64 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Zinc Picolinate 15 Mg
    zinc picolinate, 15 mg/day for 6 months

Primary outcome measures

  • Metal biomonitoring to compare change from baseline versus zinc supplement [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 (2)
  • DNA damage assays to compare change from baseline versus zinc supplement [Time frame: 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 [Time frame: Visit 1 (0 months-baseline 1), Visit 2 (3 months-baseline 2), Visit 3 (6 months-zinc 1), Visit 4 (9 months-zinc 2)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 1 center
  • University of New Mexico Health Sciences Center — Albuquerque

Identifiers

NCT: NCT03908736 · 18-381

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗