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

Primary Purpose

DNA Damage, Immune System Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Zinc Picolinate 15 Mg
Sponsored by
University of New Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for DNA Damage

Eligibility Criteria

21 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of New Mexico Health Sciences CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single-arm cohort

Arm Description

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.

Outcomes

Primary Outcome Measures

Metal biomonitoring to compare change from baseline versus zinc supplement
urinary and serum metal levels to be measured by inductively coupled plasma mass spectrometry
Lymphocyte phenotyping to compare change from baseline versus zinc supplement
Lymphocyte phenotypes will be measured in blood samples
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
Autoantibody measurement to compare change from baseline versus zinc supplement
Autoantibody panel titers will be measured in blood samples

Secondary Outcome Measures

DNA damage assays to compare change from baseline versus zinc supplement
DNA damage measurements in cells retrieved from blood samples
PARP activity assays to compare change from baseline versus zinc supplement
Activity measurement of the DNA repair enzyme poly (ADP ribose) polymerase (PARP)

Full Information

First Posted
April 1, 2019
Last Updated
August 8, 2023
Sponsor
University of New Mexico
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1. Study Identification

Unique Protocol Identification Number
NCT03908736
Brief Title
Thinking Zinc: a Study of Zinc Supplements on the Navajo Nation
Official Title
Thinking Zinc: A Study of Zinc Supplementation to Ameliorate Adverse Effects of Mine Waste Exposure on the Navajo Nation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 19, 2019 (Actual)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of New Mexico

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
DNA Damage, Immune System Disorder

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single-arm cohort
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Zinc Picolinate 15 Mg
Intervention Description
zinc picolinate, 15 mg/day for 6 months
Primary Outcome Measure Information:
Title
Metal biomonitoring to compare change from baseline versus zinc supplement
Description
urinary and serum metal levels to be measured by inductively coupled plasma mass spectrometry
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)
Title
Lymphocyte phenotyping to compare change from baseline versus zinc supplement
Description
Lymphocyte phenotypes will be measured in blood samples
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)
Title
Cytokine level measurement to compare change from baseline versus zinc supplement
Description
A cytokine panel will be used to measure levels of multiple cytokines in blood samples
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)
Title
Autoantibody measurement to compare change from baseline versus zinc supplement
Description
Autoantibody panel titers will be measured in blood samples
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 Measure Information:
Title
DNA damage assays to compare change from baseline versus zinc supplement
Description
DNA damage measurements in cells retrieved from blood samples
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)
Title
PARP activity assays to compare change from baseline versus zinc supplement
Description
Activity measurement of the DNA repair enzyme poly (ADP ribose) polymerase (PARP)
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)
Other Pre-specified Outcome Measures:
Title
Exploratory outcome dietary nutritional intake
Description
Food frequency questionnaire for other nutritional factors that may have impact on immune and/or DNA damage parameters
Time Frame
Visit 2 (3 months), Visit 4 (9 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laurie G Hudson, PhD
Phone
505-272-2482
Email
lhudson@salud.unm.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Debra MacKenzie, PhD
Phone
505-272-6535
Email
dmackenzie@salud.unm.edu
Facility Information:
Facility Name
University of New Mexico Health Sciences Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurie G Hudson, PhD
Phone
505-272-2482
Email
lhudson@salud.unm.edu
First Name & Middle Initial & Last Name & Degree
Debra MacKenzie, PhD
Phone
505-272-6535
Email
DMacKenzie@salud.unm.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.

Learn more about this trial

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

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