Calcium/Vitamin D, Biomarkers,& Colon Polyp Prevention - Full Text View

Sponsors and Collaborators:	Emory University National Cancer Institute (NCI)
Information provided by:	Emory University
ClinicalTrials.gov Identifier:	NCT00399607

Purpose

We have developed a set of biomarkers of risk for colon cancer, and in this study we will test 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.

Condition	Intervention
Adenomatous Colon Polyps	Drug: Calcium and/or Vitamin D

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Factorial Assignment, Efficacy Study
Official Title:	Calcium D. Biomarkers & Colon Polyp Prevention

Resource links provided by NLM:

MedlinePlus related topics: Calcium Cancer Colonic Polyps

Drug Information available for: Calcium gluconate Vitamin D

U.S. FDA Resources

Further study details as provided by Emory University:

Primary Outcome Measures:

Investigate the effect of calcium and/or vitamin D on a panel of biomarkers of risk for colorectal cancer, if the modification is associated with decreased recurrence adenomatous polyps. [ Time Frame: December 2017 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To clarify differences among the treatment groups at the 3-5-year colonoscopies precede and may predict adenoma recurrence, [ Time Frame: December 2017 ] [ Designated as safety issue: No ]
To clarify differences in the biomarkers in rectal mucosa among the treatment groups at the 3-5-year colonoscopies also occur more proximally in the colon, [ Time Frame: December 2017 ] [ Designated as safety issue: No ]
To clarify differences in the biomarkers in rectal mucosa among the treatment groups at the 3-5-year colonoscopies are affected by colonoscopic preparation, and [ Time Frame: December 2017 ] [ Designated as safety issue: No ]
To clarify differences in biomarkers from baseline to one year are maintained, accumulative, or attenuated by 3-5 years, [ Time Frame: December 2017 ] [ Designated as safety issue: No ]
Estimate the normal variability of the biomarker panel in sporadic adenoma patients over time. [ Time Frame: 12/2007 ] [ Designated as safety issue: No ]
Investigate whether biomarker responses to treatments vary according to nonsteroidal anti-inflammatory drug (NSAID) use or vitamin D receptor (VDR) genotype. [ Time Frame: 12/2007 ] [ Designated as safety issue: No ]

Estimated Enrollment:	1328
Study Start Date:	June 2006
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Calcium 1200 mg	Drug: Calcium and/or Vitamin D Calcium will be given in a 1200 mg dose in a pill, twice daily for either 3 or 5 years. Vitamin D will be given in a 1000 IU dose in a pill, twice daily for either 3 or 5 years.
2: Experimental Vitamin D, 1000IU	Drug: Calcium and/or Vitamin D Calcium will be given in a 1200 mg dose in a pill, twice daily for either 3 or 5 years. Vitamin D will be given in a 1000 IU dose in a pill, twice daily for either 3 or 5 years.

Show Detailed Description

Eligibility

Ages Eligible for Study:	45 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

45 - 75 years old.
≥ 1 histologically-verified neoplastic polyps, ≥ 2 mm in diameter, removed from the large bowel within 4 months of study entry, with entire large bowel examined by colonoscopy and documented free of further polyps.
Willing to follow the study protocol, as indicated by the subject's informed consent to participate.
Good general health, with no severely debilitating diseases or active malignancy that might compromise the patient's ability to complete the study.
Anticipated colonoscopic follow up three years or five years after the qualifying colonoscopy.

Exclusion Criteria:

Invasive carcinoma in any colonic polyp removed.
Familial colonic polyposis syndromes.
Ulcerative colitis or Crohn's disease.
Malabsorption syndrome (e.g., pancreatic insufficiency).
History of large bowel resection for any reason.
Diagnosed narcotic or alcohol dependence.
Elevated serum calcium or creatinine, or supraphysiologic levels of 25(OH) vitamin D at study entry.
Current use of thiazide diuretic in amount greater than the equivalent of 50 mg of hydrochlorothiazide.
New York Heart Association Cardiovascular Disease functional class 3 or 4.
On renal dialysis.
History of kidney stones, unexplained hematuria, or sarcoidosis in the previous 20 years.
Any history of hypo- or hyperparathyroidism.
Unwilling to forgo individual calcium and vitamin D supplementation during the trial.
Unwilling to forgo daily intake of more than a quart of milk (or equivalent in other dairy products) or daily dietary intake of vitamin D estimated to be greater than 400 IU.
History of osteoporosis or other medical condition that may require supplemental calcium or vitamin D.
Current use of bisphonates (eg, alendronate [Fosamax], risendronate [Actonel]).
Current use of calcitonins (eg, Miacalcin).

Additional exclusion criteria for the adjunct biomarker study are:

Unable to be off aspirin for 7 days.
History of bleeding disorder or current use of anticoagulant medication.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00399607

Contacts

Contact: Roberd M Bostick, MD, MPH	404 727 2671	rmbosti@sph.emory.edu
Contact: Jill J Davison, MPH	404 727 2725	jjdavis@sph.emory.edu

Locations

United States, California
USC/Norris Comprehensice Cancer Center	Recruiting
Los Angeles-, California, United States, 90089
Principal Investigator: Robert W Haile, Dr. PH
United States, Colorado
University of Colorado Health Sciences Center	Recruiting
Denver, Colorado, United States, 80220
Principal Investigator: Dennis Ahnen, MD
United States, Georgia
Emory University	Recruiting
Atlanta, Georgia, United States, 30322
Principal Investigator: Roberd M Bostick, MD
United States, Iowa
University of Iowa Hospitals & Clinic	Recruiting
Iowa City, Iowa, United States, 52242
Principal Investigator: Robert W Summers, MD
United States, Minnesota
University of Minnesota	Recruiting
Minneapolis, Minnesota, United States, 55455
Principal Investigator: Tim Church, Ph.D.
United States, New Hampshire
Dartmouth-Hitchcock Medical Center	Recruiting
Lebanon, New Hampshire, United States, 03756
Principal Investigator: John A Baron, MD
Sub-Investigator: Richard Rothstein, MD
United States, North Carolina
University of North Carolina	Recruiting
Chapel Hill, North Carolina, United States, 27599
Principal Investigator: Robert S Sandler, MD
United States, Ohio
Cleveland Clinic Foundation	Recruiting
Cleveland, Ohio, United States, 44195
Principal Investigator: Carol Burke, MD
United States, South Carolina
University of South Carolina	Recruiting
West Columbia, South Carolina, United States, 29039
Principal Investigator: Roberd M Bostick, MD
Sub-Investigator: March E Seabrook, MD

Sponsors and Collaborators

Emory University

National Cancer Institute (NCI)

Investigators

Study Director:	Roberd m Bostick, MD, MPH	Emory University
Principal Investigator:	Jack S Mandel, Ph.D	Emory University
Principal Investigator:	Robin Rutherford, MD	Emory Healthcare
Principal Investigator:	Dana W Flanders, Ph.D.	Emory University

More Information

No publications provided

Responsible Party:	Emory University ( Roberd M. Bostick, MD, MPH, Professor of Epidemiology )
Study ID Numbers:	RO1 CA 114456-01A1
Study First Received:	November 13, 2006
Last Updated:	September 8, 2008
ClinicalTrials.gov Identifier:	NCT00399607 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Ergocalciferol
Colonic Polyps
Ergocalciferols
Polyps
Bone Density Conservation Agents
Trace Elements

Calcium, Dietary
Vitamin D
Vitamin D2
Vitamins
Micronutrients
Calciferol

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Vitamin D
Intestinal Polyps
Growth Substances
Vitamins
Physiological Effects of Drugs

Ergocalciferols
Colonic Polyps
Bone Density Conservation Agents
Polyps
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 11, 2009