Zinc Supplements in Lowering Cadmium Levels in Smokers
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|ClinicalTrials.gov Identifier: NCT00376987|
Recruitment Status : Completed
First Posted : September 15, 2006
Last Update Posted : May 30, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer Cervical Cancer Esophageal Cancer Gastric Cancer Head and Neck Cancer Kidney Cancer Leukemia Liver Cancer Lung Cancer Pancreatic Cancer Tobacco Use Disorder||Dietary Supplement: zinc oxide||Phase 2|
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||61 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Do Dietary Supplements of Zinc Reduce Serum Cadmium Levels in Smokers?|
|Study Start Date :||December 2003|
|Actual Primary Completion Date :||October 2006|
|Actual Study Completion Date :||June 2015|
- Dietary Supplement: zinc oxide
Oral daily dietary supplement containing 80 mg Zinc oxide
- Reduction of cadmium levels [ Time Frame: 17 weeks ]
- Serum levels of cotinine, zinc, and cadmium at 3 pre-supplementation visits and at 6 supplementation visits [ Time Frame: 17 weeks ]
- Correlation of increased cadmium levels with decreased mismatch repair [ Time Frame: 17 weeks ]
- Reversal of cadmium-induced inhibition of mismatch repair [ Time Frame: 17 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00376987
|United States, North Carolina|
|Wake Forest University Comprehensive Cancer Center|
|Winston-Salem, North Carolina, United States, 27157-1096|
|Principal Investigator:||Gary G. Schwartz, MD, PhD, MPH||Wake Forest University Health Sciences|