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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00376987
Other study ID # CDR0000495325
Secondary ID CCCWFU-98903CCCW
Status Completed
Phase Phase 2
First received September 13, 2006
Last updated May 25, 2017
Start date December 2003
Est. completion date June 2015

Study information

Verified date September 2015
Source Wake Forest University Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 61
Est. completion date June 2015
Est. primary completion date October 2006
Accepts healthy volunteers No
Gender All
Age group 21 Years to 120 Years
Eligibility 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

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

Intervention

Dietary Supplement:
zinc oxide
Oral daily dietary supplement containing 80 mg Zinc oxide

Locations

Country Name City State
United States Wake Forest University Comprehensive Cancer Center Winston-Salem North Carolina

Sponsors (2)

Lead Sponsor Collaborator
Wake Forest University Health Sciences National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Reduction of cadmium levels 17 weeks
Primary Serum levels of cotinine, zinc, and cadmium at 3 pre-supplementation visits and at 6 supplementation visits 17 weeks
Primary Correlation of increased cadmium levels with decreased mismatch repair 17 weeks
Primary Reversal of cadmium-induced inhibition of mismatch repair 17 weeks
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