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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03908736
Other study ID # 18-381
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 19, 2019
Est. completion date December 2025

Study information

Verified date August 2023
Source University of New Mexico
Contact Laurie G Hudson, PhD
Phone 505-272-2482
Email lhudson@salud.unm.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a study to assess the effect of dietary zinc supplementation to mitigate biomarkers of metal toxicity in exposed tribal populations.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 2025
Est. primary completion date July 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 64 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States University of New Mexico Health Sciences Center Albuquerque New Mexico

Sponsors (1)

Lead Sponsor Collaborator
University of New Mexico

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Exploratory outcome dietary nutritional intake Food frequency questionnaire for other nutritional factors that may have impact on immune and/or DNA damage parameters Visit 2 (3 months), Visit 4 (9 months)
Primary Metal biomonitoring to compare change from baseline versus zinc supplement urinary and serum metal levels to be measured by inductively coupled plasma mass spectrometry Visit 1 (0 months-baseline 1), Visit 2 (3 months-baseline 2), Visit 3 (6 months-zinc 1), Visit 4 (9 months-zinc 2)
Primary Lymphocyte phenotyping to compare change from baseline versus zinc supplement Lymphocyte phenotypes will be measured in blood samples Visit 1 (0 months-baseline 1), Visit 2 (3 months-baseline 2), Visit 3 (6 months-zinc 1), Visit 4 (9 months-zinc 2)
Primary 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 Visit 1 (0 months-baseline 1), Visit 2 (3 months-baseline 2), Visit 3 (6 months-zinc 1), Visit 4 (9 months-zinc 2)
Primary Autoantibody measurement to compare change from baseline versus zinc supplement Autoantibody panel titers will be measured in blood samples 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 DNA damage assays to compare change from baseline versus zinc supplement DNA damage measurements in cells retrieved from blood samples 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 PARP activity assays to compare change from baseline versus zinc supplement Activity measurement of the DNA repair enzyme poly (ADP ribose) polymerase (PARP) Visit 1 (0 months-baseline 1), Visit 2 (3 months-baseline 2), Visit 3 (6 months-zinc 1), Visit 4 (9 months-zinc 2)
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