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

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ClinicalTrials.gov Identifier: NCT03908736
Recruitment Status : Recruiting
First Posted : April 9, 2019
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
DNA Damage Immune System Disorder Drug: Zinc Picolinate 15 Mg Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Intervention Model Description: This is a one-armed cohort intervention of zinc supplementation. Data will be collected for each participant before and after zinc supplementation.
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Thinking Zinc: A Study of Zinc Supplementation to Ameliorate Adverse Effects of Mine Waste Exposure on the Navajo Nation
Actual Study Start Date : May 19, 2019
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



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Ages Eligible for Study:   21 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03908736


Contacts
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Contact: Laurie G Hudson, PhD 505-272-2482 lhudson@salud.unm.edu
Contact: Debra MacKenzie, PhD 505-272-6535 dmackenzie@salud.unm.edu

Locations
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United States, New Mexico
University of New Mexico Health Sciences Center Recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Laurie G Hudson, PhD    505-272-2482    lhudson@salud.unm.edu   
Contact: Debra MacKenzie, PhD    505-272-6535    DMacKenzie@salud.unm.edu   
Sponsors and Collaborators
University of New Mexico

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Responsible Party: University of New Mexico
ClinicalTrials.gov Identifier: NCT03908736     History of Changes
Other Study ID Numbers: 18-381
First Posted: April 9, 2019    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Immune System Diseases
Zinc
Picolinic acid
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Iron Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action