NCT00376987

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2003

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2006

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
8.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

May 30, 2017

Status Verified

September 1, 2015

Enrollment Period

2.8 years

First QC Date

September 13, 2006

Last Update Submit

May 25, 2017

Conditions

Bladder CancerCervical CancerEsophageal CancerGastric CancerHead and Neck CancerKidney CancerLeukemiaLiver CancerLung CancerPancreatic CancerTobacco Use Disorder

Keywords

renal cell carcinomabladder cancercervical canceresophageal cancergastric canceradult acute myeloid leukemiapancreatic cancerhypopharyngeal cancerlip and oral cavity cancerlaryngeal cancernasopharyngeal canceroropharyngeal cancerparanasal sinus and nasal cavity cancernon-small cell lung cancersmall cell lung canceradult primary liver cancertongue cancertobacco use disorder

Outcome Measures

Primary Outcomes (4)

  • Reduction of cadmium levels

    17 weeks

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

    17 weeks

  • Correlation of increased cadmium levels with decreased mismatch repair

    17 weeks

  • Reversal of cadmium-induced inhibition of mismatch repair

    17 weeks

Interventions

zinc oxideDIETARY_SUPPLEMENT

Oral daily dietary supplement containing 80 mg Zinc oxide

Eligibility Criteria

Age21 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Wake Forest University Comprehensive Cancer Center

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

Location

MeSH Terms

Conditions

Urinary Bladder NeoplasmsUterine Cervical NeoplasmsEsophageal NeoplasmsStomach NeoplasmsHead and Neck NeoplasmsKidney NeoplasmsLeukemiaLiver NeoplasmsLung NeoplasmsPancreatic NeoplasmsTobacco Use DisorderCarcinoma, Renal CellLeukemia, Myeloid, AcuteHypopharyngeal NeoplasmsMouth NeoplasmsLaryngeal NeoplasmsNasopharyngeal NeoplasmsOropharyngeal NeoplasmsCarcinoma, Non-Small-Cell LungSmall Cell Lung CarcinomaCarcinoma, HepatocellularTongue Neoplasms

Interventions

Zinc Oxide

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleGenital DiseasesGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesStomach DiseasesKidney DiseasesNeoplasms by Histologic TypeHematologic DiseasesHemic and Lymphatic DiseasesLiver DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System DiseasesSubstance-Related DisordersChemically-Induced DisordersMental DisordersAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialLeukemia, MyeloidPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic DiseasesMouth DiseasesLaryngeal DiseasesNasopharyngeal DiseasesCarcinoma, BronchogenicBronchial NeoplasmsTongue Diseases

Intervention Hierarchy (Ancestors)

OxidesOxygen CompoundsInorganic ChemicalsZinc Compounds

Study Officials

  • Gary G. Schwartz, MD, PhD, MPH

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2006

First Posted

September 15, 2006

Study Start

December 1, 2003

Primary Completion

October 1, 2006

Study Completion

June 1, 2015

Last Updated

May 30, 2017

Record last verified: 2015-09

Locations

US(1)