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

NCT03908736 | Recruiting DMC

• 1 other identifier: 18-381
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• 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)

• 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)

• 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)

• 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 Outcomes (2)

• DNA damage assays 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)

• PARP activity assays 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)

Other Outcomes (1)

• Exploratory outcome dietary nutritional intake

  Visit 2 (3 months), Visit 4 (9 months)

Study Arms (1)

Single-arm cohort

OTHER

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.

Drug: Zinc Picolinate 15 Mg

Interventions

Zinc Picolinate 15 Mg DRUG

zinc picolinate, 15 mg/day for 6 months

Single-arm cohort

Eligibility Criteria

• Age: 21 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of New Mexico: lead

Study Sites (1)

University of New Mexico Health Sciences Center

Albuquerque, New Mexico, 87131, United States

RECRUITING

MeSH Terms

Conditions

Immune System Diseases

Interventions

picolinic acid

Central Study Contacts

Laurie G Hudson, PhD

CONTACT

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

Debra MacKenzie, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a one-armed cohort intervention of zinc supplementation. Data will be collected for each participant before and after zinc supplementation.

Study Record Dates

• First Submitted: April 1, 2019
• First Posted: April 9, 2019
• Study Start: May 19, 2019
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)