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COMPLETED

Calcium/Vitamin D, Biomarkers & Colon Polyp Prevention

NCT00399607 · View on ClinicalTrials.gov ↗

Study Summary

The study team has developed a set of biomarkers of risk for colon cancer; this study tests 1) whether or not calcium and/or vitamin D supplementation can favorably affect these biomarkers in persons who are at higher than average risk for colon cancer (ie, have already undergone the removal of colon growths, called adenomatous polyps, which are known to be precursors to developing colon cancer), and 2) whether effects on the biomarkers predict who will get new colon polyps or not.

Interventions

  • PROCEDURE Rectal biopsy during colonoscopy
  • PROCEDURE Rectal biopsy at randomization
  • PROCEDURE Rectal biopsy at 1 year
  • PROCEDURE Rectal biopsy prior to colonoscopy
  • PROCEDURE Biopsies during colonoscopy

Study Locations (9)

California

  • USC/Norris Comprehensice Cancer Center — Los Angeles

Colorado

  • University of Colorado Health Sciences Center — Denver

Georgia

  • Emory University — Atlanta

Iowa

  • University of Iowa Hospitals & Clinic — Iowa City

Minnesota

  • University of Minnesota — Minneapolis

New Hampshire

  • Dartmouth-Hitchcock Medical Center — Lebanon

North Carolina

  • University of North Carolina — Chapel Hill

Ohio

  • Cleveland Clinic Foundation — Cleveland

Trial Details

FieldValue
Enrollment Target 264 participants
Start Date 2006-06
Est. Completion 2016-08

Sponsor

Emory University

1,434 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00399607

The ClinicalTrials.gov registry entry for NCT00399607 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 264 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emory University, which has 1,434 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Colorectal Adenomatous Polyps appearing as the primary indexed condition, and to 5 interventions — of which Rectal biopsy during colonoscopy is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00399607 reports 9 study locations spanning 9 distinct geographic areas — top geographies include California, Colorado, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00399607 about?

NCT00399607 is a clinical study titled "Calcium/Vitamin D, Biomarkers & Colon Polyp Prevention". The study team has developed a set of biomarkers of risk for colon cancer; this study tests 1) whether or not calcium and/or vitamin D supplementation can favorably affect these biomarkers in persons who are at higher than average risk for colon cancer (ie, have already undergone the removal of colo...

What is the current status of trial NCT00399607?

This trial is currently completed. The enrollment target is 264 participants. The study started on 2006-06. Estimated completion is 2016-08.

What conditions does trial NCT00399607 study?

This clinical trial studies the following conditions: Colorectal Adenomatous Polyps. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00399607?

The interventions under investigation include: Rectal biopsy during colonoscopy (PROCEDURE), Rectal biopsy at randomization (PROCEDURE), Rectal biopsy at 1 year (PROCEDURE), Rectal biopsy prior to colonoscopy (PROCEDURE), Biopsies during colonoscopy (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00399607?

This trial is sponsored by Emory University, which has 1,434 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00399607 being conducted?

This trial has 9 study locations across California, Colorado, Georgia, Iowa, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial