Zinc Supplements in Lowering Cadmium Levels in Smokers
This study is ongoing, but not recruiting participants.
Sponsor:
Comprehensive Cancer Center of Wake Forest University
Collaborator:
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT00376987
First received: September 13, 2006
Last updated: June 28, 2012
Last verified: June 2012
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Purpose
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 | Intervention | 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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Do Dietary Supplements of Zinc Reduce Serum Cadmium Levels in Smokers? |
Resource links provided by NLM:
Genetics Home Reference related topics:
bladder cancer
MedlinePlus related topics:
Bladder Cancer
Cancer
Cervical Cancer
Dietary Supplements
Esophageal Cancer
Esophagus Disorders
Head and Neck Cancer
Kidney Cancer
Leukemia
Liver Cancer
Lung Cancer
Pancreatic Cancer
Stomach Cancer
U.S. FDA Resources
Further study details as provided by Comprehensive Cancer Center of Wake Forest University:
Primary Outcome Measures:
- Reduction of cadmium levels [ Time Frame: 17 weeks ] [ Designated as safety issue: No ]
- Serum levels of cotinine, zinc, and cadmium at 3 pre-supplementation visits and at 6 supplementation visits [ Time Frame: 17 weeks ] [ Designated as safety issue: No ]
- Correlation of increased cadmium levels with decreased mismatch repair [ Time Frame: 17 weeks ] [ Designated as safety issue: No ]
- Reversal of cadmium-induced inhibition of mismatch repair [ Time Frame: 17 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 61 |
| Study Start Date: | December 2003 |
| Primary Completion Date: | October 2006 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Dietary Supplement: zinc oxide
Oral daily dietary supplement containing 80 mg Zinc oxide
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.
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00376987
Locations
| United States, North Carolina | |
| Wake Forest University Comprehensive Cancer Center | |
| Winston-Salem, North Carolina, United States, 27157-1096 | |
Sponsors and Collaborators
Comprehensive Cancer Center of Wake Forest University
Investigators
| Principal Investigator: | Gary G. Schwartz, MD, PhD, MPH | Comprehensive Cancer Center of Wake Forest University |
More Information
Additional Information:
No publications provided
| Responsible Party: | Comprehensive Cancer Center of Wake Forest University |
| ClinicalTrials.gov Identifier: | NCT00376987 History of Changes |
| Other Study ID Numbers: | CDR0000495325, CCCWFU-98903, CCCWFU-BG03-538 |
| Study First Received: | September 13, 2006 |
| Last Updated: | June 28, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Comprehensive Cancer Center of Wake Forest University:
|
renal cell carcinoma bladder cancer cervical cancer esophageal cancer gastric cancer adult acute myeloid leukemia pancreatic cancer hypopharyngeal cancer lip and oral cavity cancer |
laryngeal cancer nasopharyngeal cancer oropharyngeal cancer paranasal sinus and nasal cavity cancer non-small cell lung cancer small cell lung cancer adult primary liver cancer tongue cancer tobacco use disorder |
Additional relevant MeSH terms:
|
Urinary Bladder Neoplasms Carcinoma, Renal Cell Kidney Neoplasms Uterine Cervical Neoplasms Esophageal Diseases Esophageal Neoplasms Head and Neck Neoplasms Leukemia Liver Neoplasms Lung Neoplasms Stomach Neoplasms Pancreatic Neoplasms Tobacco Use Disorder Urologic Neoplasms Urogenital Neoplasms |
Neoplasms by Site Neoplasms Urinary Bladder Diseases Urologic Diseases Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Kidney Diseases Uterine Neoplasms Genital Neoplasms, Female Uterine Cervical Diseases Uterine Diseases Genital Diseases, Female Gastrointestinal Diseases |
ClinicalTrials.gov processed this record on June 17, 2013