Thinking Zinc: a Study of Zinc Supplements on the Navajo Nation
- Conditions
- DNA DamageImmune System Disorder
- Registration Number
- NCT03908736
- Lead Sponsor
- University of New Mexico
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Men or women between the ages of 21 and 64 years of age<br><br> - Lives in or near the participating communities of Blue Gap-Tachee Arizona or Red<br> Water Pond Road Community New Mexico<br><br> - Willing to provide blood and urine samples<br><br> - Willing to attend study visits on scheduled dates<br><br> - Willing to take a daily zinc supplement<br><br>Exclusion Criteria:<br><br> - Women who are pregnant or nursing or women who plan to become pregnant during the<br> course of the study.<br><br> - Individuals who have self-reported diabetes, report that they are undergoing<br> treatment for diabetes, or are currently taking medication for diabetes.<br><br> - Known or suspected allergy to zinc.<br><br> - Individuals previously diagnosed with syndromes of copper homeostasis (Menkes<br> disease or Wilsons disease).<br><br> - Individuals consuming zinc supplements or multivitamins and are unwilling to stop<br> for the duration of the study.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Metal biomonitoring to compare change from baseline versus zinc supplement;Lymphocyte phenotyping to compare change from baseline versus zinc supplement;Cytokine level measurement to compare change from baseline versus zinc supplement;Autoantibody measurement to compare change from baseline versus zinc supplement
- Secondary Outcome Measures
Name Time Method DNA damage assays to compare change from baseline versus zinc supplement;PARP activity assays to compare change from baseline versus zinc supplement