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
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 |
This is a study to assess the effect of dietary zinc supplementation to mitigate biomarkers of metal toxicity in exposed tribal populations.
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. |
Country | Name | City | State |
---|---|---|---|
United States | University of New Mexico Health Sciences Center | Albuquerque | New Mexico |
Lead Sponsor | Collaborator |
---|---|
University of New Mexico |
United States,
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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