Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03908736
Other study ID # 18-381
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 19, 2019
Est. completion date December 2025

Study information

Verified date August 2023
Source University of New Mexico
Contact Laurie G Hudson, PhD
Phone 505-272-2482
Email lhudson@salud.unm.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

Communities living in proximity to abandoned uranium mines have documented exposures to metals in drinking water, soil and dust. Exposure to these metals, principally uranium and arsenic, and metal mixtures is associated with dysregulation of immune function and other health effects. The objective of this study is to conduct an intervention trial to assess the effect of dietary zinc supplementation to mitigate the toxicity of metal exposures. The current project is part of a larger research effort funded by the NIH Superfund Program to study environmental metals exposures in tribal communities in New Mexico.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 2025
Est. primary completion date July 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 64 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
Zinc Picolinate 15 Mg
zinc picolinate, 15 mg/day for 6 months

Locations

Country Name City State
United States University of New Mexico Health Sciences Center Albuquerque New Mexico

Sponsors (1)

Lead Sponsor Collaborator
University of New Mexico

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Exploratory outcome dietary nutritional intake Food frequency questionnaire for other nutritional factors that may have impact on immune and/or DNA damage parameters Visit 2 (3 months), Visit 4 (9 months)
Primary 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)
Primary 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)
Primary 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)
Primary 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 DNA damage assays to compare change from baseline versus zinc supplement DNA damage measurements in cells retrieved from 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 PARP activity assays to compare change from baseline versus zinc supplement Activity measurement of the DNA repair enzyme poly (ADP ribose) polymerase (PARP) Visit 1 (0 months-baseline 1), Visit 2 (3 months-baseline 2), Visit 3 (6 months-zinc 1), Visit 4 (9 months-zinc 2)
See also
  Status Clinical Trial Phase
Completed NCT01677169 - Effect of Noni Juice on Lipid Peroxidation-derived DNA Adducts in Heavy Smokers Phase 2
Recruiting NCT04372914 - Prevention of Oral DNA Damage by Black Raspberries N/A
Completed NCT03319654 - Impact of DNA Fragmentation in Sperm on Pregnancy Outcome After Intra-uterine Insemination in a Spontaneous Cycle N/A
Terminated NCT03893617 - Brief Stresses Experimental Study Phase 1
Active, not recruiting NCT06204523 - Prospective Validation of a DNA Damage Repair-Hippo Pathway Signature in Patients With Advanced Gastric Cancer
Completed NCT02696811 - The Effects of Foods on Cell Damage Study N/A
Completed NCT01461395 - Polscope Sperm: A Non-invasive Method to Assess DNA Damage in Individual Sperm N/A
Recruiting NCT04081428 - Using Breath, Cell Free DNA and Image Analysis to PRedIct Normal TissUe and Tumour Response During Prostate Cancer SBRT
Not yet recruiting NCT05558046 - Predictive Value of Granulosa Cell DNA Damage in the Success of Assisted Reproductive Technique
Recruiting NCT04795440 - Comparison of ICSI Outcomes in Cycles Using Testicular and Ejaculate Sperm From Couples With High SDF N/A
Completed NCT05306002 - Nutritional Intervention and DNA Damage of Patients With HBOC N/A
Completed NCT04772703 - DNA Damage in Critically Ill COVID-19 Patients
Completed NCT05111717 - The Effect of Desfluran On Global Dna Methylation
Recruiting NCT05596149 - Assessment of the Cytotoxic and Genotoxic Effect of Toothpastes With Different Forms of Fluoride on the Buccal Mucosa N/A
Completed NCT04721938 - Healthy Parents - Healthy Children. Weight Loss Before Fertility Treatment N/A
Recruiting NCT03652142 - Predictive Biomarkers for Response to Nivolumab in Head and Neck Squamous Cell Carcinoma
Completed NCT00854178 - Toxicogenomic and Immunocytotoxic Effects of Propofol and Isoflurane Anesthetics in Patients Undergoing Elective Surgery Phase 4
Active, not recruiting NCT05277961 - Quantification of DNA Repair Products in the Urine After Ultraviolet Radiation of the Skin N/A
Completed NCT02058082 - Testicular Versus Ejaculated Spermatozoa for IVF/ICSI in Men With High Sperm DNA Damage N/A
Completed NCT05055154 - Oxidative Stress and L-CBMN Cytome Assay in Obese After 3 Weeks VLCD N/A