NCT00376987

Zinc Supplements in Lowering Cadmium Levels in Smokers

Do Dietary Supplements of Zinc Reduce Serum Cadmium Levels in Smokers?

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 21 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Bladder Cancer
• Cervical Cancer
• Esophageal Cancer
• Gastric Cancer
• Head and Neck Cancer
• Kidney Cancer
• Leukemia
• Liver Cancer
• Lung Cancer
• Pancreatic Cancer
• Tobacco Use Disorder

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	zinc oxide	Oral daily dietary supplement containing 80 mg Zinc oxide

Timeline

• Start date: 2003-12-01
• Primary completion: 2006-10-01
• Completion: 2015-06-01
• First posted: 2006-09-15
• Last updated: 2017-05-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study