Zinc Supplements in Lowering Cadmium Levels in Smokers

Lung Cancer Clinical Trial

Official title:

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

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
• 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

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