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Clinical trial

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

ID
Name
18-381
Description
This is a study to assess the effect of dietary zinc supplementation to mitigate biomarkers of metal toxicity in exposed tribal populations.
Trial arms
Trial start
2019-05-19
Estimated PCD
2025-07-01
Trial end
2025-12-01
Status
Recruiting
Treatment
Zinc Picolinate 15 Mg
zinc picolinate, 15 mg/day for 6 months
Arms:
Single-arm cohort
Size
100
Primary endpoint
Metal biomonitoring to compare change from baseline versus zinc supplement
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 phenotyping to compare change from baseline versus zinc supplement
Visit 1 (0 months-baseline 1), Visit 2 (3 months-baseline 2), Visit 3 (6 months-zinc 1), Visit 4 (9 months-zinc 2)
Cytokine level measurement to compare change from baseline versus zinc supplement
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 measurement to compare change from baseline versus zinc supplement
Visit 1 (0 months-baseline 1), Visit 2 (3 months-baseline 2), Visit 3 (6 months-zinc 1), Visit 4 (9 months-zinc 2)
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This is a one-armed cohort intervention of zinc supplementation. Data will be collected for each participant before and after zinc supplementation.', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}
Updated at
2023-08-14

1 organization

1 product

2 indications

Organization
University of New Mexico
Product
Zinc Picolinate
Indication
DNA damage
Indication
Immune System Disorder