RecruitingPhase 2

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

United States100 participantsStarted 2019-05-19

Plain-language summary

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

Who can participate

Age range

21 Years – 64 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Metal biomonitoring to compare change from baseline versus zinc supplement

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: Visit 1 (0 months-baseline 1), Visit 2 (3 months-baseline 2), Visit 3 (6 months-zinc 1), Visit 4 (9 months-zinc 2)

Trial details

NCT IDNCT03908736

SponsorUniversity of New Mexico

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-07

Contact for this trial

Laurie G Hudson, PhD

505-272-2482 lhudson@salud.unm.edu

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