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

DNA Damage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03908736
• Other study ID #: 18-381
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• DNA Damage
• Immune System Diseases
• Immune System Disorder

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)