Recruiting
Phase 2

Zinc Supplements

Sponsor:

University of New Mexico

Code:

NCT03908736

Conditions

DNA Damage

Immune System Disorder

Eligibility Criteria

Sex: All

Age: 21 - 64

Healthy Volunteers: Accepted

Interventions

Zinc Picolinate 15 Mg

Study Details

Brief summary:

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

Conditions

DNA Damage

Immune System Disorder

Study ID

NCT03908736

Start date

May 19, 2019

Status verified date

Jun, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 64

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

other: Single-arm cohort

Baseline experimental measurements will be collected for each individual participant twice prior to zinc supplementation (0 month and 3 month time points). After zinc supplementation, experimental measurements will be collected for each individual participant at the 6 month and 9 month time points. The zinc intervention is zinc picolinate 15 mg once per day for 6 months.

Interventions

Zinc Picolinate 15 Mg

zinc picolinate, 15 mg/day for 6 months

Primary outcome measure

  • Metal biomonitoring to compare change from baseline versus zinc supplement [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Visit 1 (0 months-baseline 1), Visit 2 (3 months-baseline 2), Visit 3 (6 months-zinc 1), Visit 4 (9 months-zinc 2) ]

Central Contacts and Locations

Central contacts

Laurie G Hudson, PhD

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

Debra MacKenzie, PhD

505-272-6535dmackenzie@salud.unm.edu

Locations

University of New Mexico Health Sciences Center

Recruiting

Albuquerque, New Mexico, United States, 87131

Contacts

Laurie G Hudson, PhD

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

Debra MacKenzie, PhD

505-272-6535DMacKenzie@salud.unm.edu

More Information

Sponsor

University of New Mexico

Last update posted

Jun 4, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of New Mexico on 2026-06-04.