Thinking Zinc: a Study of Zinc Supplements on the Navajo Nation
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age21-64
SponsorUniversity of New Mexico
About this trial
This is a study to assess the effect of dietary zinc supplementation to mitigate biomarkers of metal toxicity in exposed tribal populations.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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).
Trial design
Design model
Single group
Treatments tested in this trial
Zinc Picolinate 15 Mg
Drugzinc picolinate, 15 mg/day for 6 months
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Single-arm cohortOther 1 intervention
Trial outcomes
Primary outcomes
1
Metal biomonitoring to compare change from baseline versus zinc supplement
urinary and serum metal levels to be measured by inductively coupled plasma mass spectrometry
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)2
Lymphocyte phenotyping to compare change from baseline versus zinc supplement
Lymphocyte phenotypes will be measured in blood samples
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)3
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
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)4
Autoantibody measurement to compare change from baseline versus zinc supplement
Autoantibody panel titers will be measured in blood samples
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)Secondary outcomes
1
DNA damage assays to compare change from baseline versus zinc supplement
DNA damage measurements in cells retrieved from blood samples
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)2
PARP activity assays to compare change from baseline versus zinc supplement
Activity measurement of the DNA repair enzyme poly (ADP ribose) polymerase (PARP)
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)Other outcomes
1
Exploratory outcome dietary nutritional intake
Food frequency questionnaire for other nutritional factors that may have impact on immune and/or DNA damage parameters
Time frame
Visit 2 (3 months), Visit 4 (9 months)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov