Zinc Supplements in Lowering Cadmium Levels in Smokers

Status Completed

Clinical Trial Summary

RATIONALE: Zinc supplements may lower cadmium levels in smokers and may help prevent DNA damage.

PURPOSE: This clinical trial is studying how well zinc supplements work in lowering cadmium levels in smokers.

Clinical Trial Description

OBJECTIVES:

- Determine whether zinc supplements reduce cadmium levels in smokers.

- Measure serum levels of cotinine (a biomarker of smoking), zinc (a marker of compliance), and cadmium (the dependent variable) at 3 pre-supplementation visits and at 6 supplementation visits.

- Determine whether serum cadmium levels (adjusted for serum levels of cotinine) decrease during supplementation with VisiVite Smoker's Formula.

- Determine if increased cadmium levels in the blood of cigarette smokers can be correlated with decreased mismatch repair.

- Determine if administration of zinc-containing supplements reverses cadmium-induced inhibition of mismatch repair.

OUTLINE: This is an open-label, nonrandomized study.

Patients receive oral zinc supplements once daily for 12 weeks in the absence of unacceptable toxicity.

Blood, serum, and urine are collected once weekly for 3 weeks before beginning treatment and in weeks 5, 6, 9, 12, 15, and 17 for biomarker/laboratory analysis. Samples are examined for cadmium, zinc, and cotinine levels by atomic absorption spectrophotometry, expression of mismatch repair proteins (MSH2, MSH6, MSH3, MLH1, and PMS2), levels of messenger RNA by reverse transcriptase-polymerase chain reaction, and microsatellite instability by gel electrophoresis.

After completion of study therapy, patients are followed for 5 weeks. ;

Study Design

Related Conditions & MeSH terms

Bladder Cancer
Carcinoma, Renal Cell
Cervical Cancer
Esophageal Cancer
Esophageal Neoplasms
Gastric Cancer
Head and Neck Cancer
Head and Neck Neoplasms
Kidney Cancer
Kidney Neoplasms
Leukemia
Liver Cancer
Liver Neoplasms
Lung Cancer
Lung Neoplasms
Pancreatic Cancer
Pancreatic Neoplasms
Stomach Neoplasms
Tobacco Use Disorder
Urinary Bladder Neoplasms
Uterine Cervical Neoplasms

Clinical Trial Details

NCT number	NCT00376987
Study type	Interventional
Source	Wake Forest University Health Sciences
Contact
Status	Completed
Phase	Phase 2
Start date	December 2003
Completion date	June 2015

View Details

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