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NCT Number: NCT03908736

Thinking Zinc: a Study of Zinc Supplements 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.

Recruiting

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Key information

Conditions

DNA Damage Immune System Diseases Immune System Disorder

Age range

21 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Zinc Picolinate 15 Mg

Drug

zinc picolinate, 15 mg/day for 6 months

Primary outcomes

  1. 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)

    urinary and serum metal levels to be measured by inductively coupled plasma mass spectrometry

  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)

    Lymphocyte phenotypes will be measured in blood samples

  3. 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)

    A cytokine panel will be used to measure levels of multiple cytokines in blood samples

  4. 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)

    Autoantibody panel titers will be measured in blood samples

Secondary outcomes

  1. 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)

    DNA damage measurements in cells retrieved from blood samples

  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)

    Activity measurement of the DNA repair enzyme poly (ADP ribose) polymerase (PARP)

Other outcomes

  1. Exploratory outcome dietary nutritional intake

    Time frame: Visit 2 (3 months), Visit 4 (9 months)

    Food frequency questionnaire for other nutritional factors that may have impact on immune and/or DNA damage parameters

Study contacts

Contact information is provided by the study sponsor or research team.

Debra MacKenzie, PhD

CONTACT

[email protected]

505-272-6535

Laurie G Hudson, PhD

CONTACT

[email protected]

505-272-2482

Sponsors and collaborators

Lead sponsor

University of New Mexico

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
Apr 9, 2019
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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