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Calcium and Vitamin D vs Markers of Adenomatous Polyps

NCT00208793 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2013-11-26

No results posted yet for this study

Summary

The purpose of this study is to test whether calcium and/or vitamin D supplementation favorably affects a set of biomarkers of risk for colon cancer in persons who are at higher than average risk for colon cancer (ie, have already undergone the removal of adenomatous polyps, which are known to be precursors to developing colon cancer).

Conditions

  • Colorectal Adenomatous Polyps

Interventions

DIETARY_SUPPLEMENT

Calcium and vitamin D3 combined

Calcium 2,000 mg (as calcium carbonate) + vitamin D3 800 IU given in equal divided doses twice daily with food over 6 months

DRUG

Placebo

Placebo

DIETARY_SUPPLEMENT

Calcium

Calcium 2,000 mg/day as calcium carbonate in two divided doses with meals over 6 months

DIETARY_SUPPLEMENT

Vitamin D3

Vitamin D3 800 IU given as 400 IU twice daily with food over 6 months

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Cancer Institute (NCI)

    collaborator NIH

  • Emory University

    lead OTHER

Principal Investigators

  • Roberd M Bostick, MD, MPH · Emory University, Rollins School of Public Health & Winship Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
30 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-05-31
Primary Completion
2006-09-30
Completion
2013-02-28

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00208793 on ClinicalTrials.gov