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Completed

NCT Number: NCT00376987

Zinc Supplements in Lowering Cadmium Levels in Smokers

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.

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Key information

Conditions

Bladder Cancer Adenocarcinoma Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Hepatocellular Carcinoma, Non-Small-Cell Lung Carcinoma, Renal Cell Cervical Cancer Chemically-Induced Disorders Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Esophageal Cancer Esophageal Diseases Esophageal Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastric Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Head and Neck Cancer Head and Neck Neoplasms Hematologic Diseases Hemic and Lymphatic Diseases Hypopharyngeal Neoplasms Kidney Cancer Kidney Diseases Kidney Neoplasms Laryngeal Diseases Laryngeal Neoplasms Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Liver Cancer Liver Diseases Liver Neoplasms Lung Cancer Lung Diseases Lung Neoplasms Male Urogenital Diseases Mental Disorders Mouth Diseases Mouth Neoplasms Nasopharyngeal Diseases Nasopharyngeal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Oropharyngeal Neoplasms Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Carcinoma Stomach Diseases Stomach Neoplasms Stomatognathic Diseases Substance-Related Disorders Thoracic Neoplasms Tobacco Use Disorder Tongue Diseases Tongue Neoplasms Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

21 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1096, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

DISEASE CHARACTERISTICS:

  • Currently smoking ≥ 1 pack (20 cigarettes) per day
  • Baseline cadmium level ≥ 0.5 μg/L

PATIENT CHARACTERISTICS:

  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No known gastrointestinal upset due to zinc vitamins or lozenges

PRIOR CONCURRENT THERAPY:

  • At least 2 weeks since prior and no other concurrent vitamins and zinc supplements

Treatment and study plan

Zinc oxide

Dietary Supplement

Oral daily dietary supplement containing 80 mg Zinc oxide

Primary outcomes

  1. Reduction of cadmium levels

    Time frame: 17 weeks

  2. Serum levels of cotinine, zinc, and cadmium at 3 pre-supplementation visits and at 6 supplementation visits

    Time frame: 17 weeks

  3. Correlation of increased cadmium levels with decreased mismatch repair

    Time frame: 17 weeks

  4. Reversal of cadmium-induced inhibition of mismatch repair

    Time frame: 17 weeks

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2006
Study completion
2015
First posted
Sep 15, 2006
Registry last updated
May 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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