Calcium/Vitamin D, Biomarkers & Colon Polyp Prevention (PPS4B)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Roberd Bostick, MD, MPH, Emory University
ClinicalTrials.gov Identifier:
NCT00399607
First received: November 13, 2006
Last updated: November 22, 2013
Last verified: November 2013
  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 Phase
Colorectal Adenomatous Polyps
Drug: Calcium
Drug: Vitamin D3
Drug: Calcium and vitamin D combined
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Calcium/Vitamin D, Biomarkers & Colon Polyp Prevention

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Biomarkers of Risk for Colorectal Neoplasms [ Time Frame: 1 year and 3 or 5 years ] [ Designated as safety issue: No ]
    Molecular phenotyping of a panel of putative biomarkers of risk for colorectal neoplasms in the normal appearing colorectal epithelium: COX-2 (cyclo-oxygenase-2), APC (adenomatous polyposis coli protein), β-catenin, E-cadherin, MLH1 (mutL homolog 1 protein), telomerase, bcl-2, bax, TGFα (transforming growth factor alpha), TGFβ1 (transforming growth factor beta 1)


Estimated Enrollment: 800
Study Start Date: June 2006
Estimated Study Completion Date: August 2016
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Calcium
Calcium 1200 mg (as calcium carbonate) in equally divided doses twice daily with food for 3 or 5 years
Drug: Calcium
Calcium 1,200 mg (as calcium carbonate) in equally divided doses twice daily with meals over 3 or 5 years
Experimental: Vitamin D3
Vitamin D3 1,000 IU given as 500 IU twice daily with food for 3 or 5 years
Drug: Vitamin D3
Vitamin D3 1,000 IU given as 500 IU twice daily with meals over 3 or 5 years
Experimental: Calcium and vitamin D3 combined
Calcium 1200 mg (as calcium carbonate) plus vitamin D3 1,000 IU in equally divided doses twice daily with food for 3 or 5 years
Drug: Calcium and vitamin D combined
Calcium 1,200 mg (as calcium carbonate) plus vitamin D3 1,000 IU given in equally divided doses twice daily with meals over 3 or 5 years
Placebo Comparator: Placebo
Placebo
Other: Placebo
Placebo given twice daily with meals over 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

Currently participating in the parent study. Not open to people not already enrolled in the parent study. This sub-study is for the collection of biopsies only, while the parent study is for calcium and vitamin D to prevent reoccurrence of colon polyps.

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 bisphosphonates (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
USC/Norris Comprehensice Cancer Center
Los Angeles-, California, United States, 90089
United States, Colorado
University of Colorado Health Sciences Center
Denver, Colorado, United States, 80220
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Iowa
University of Iowa Hospitals & Clinic
Iowa City, Iowa, United States, 52242
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, South Carolina
University of South Carolina
West Columbia, South Carolina, United States, 29039
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Roberd M Bostick, MD, MPH Emory University
  More Information

No publications provided

Responsible Party: Roberd Bostick, MD, MPH, Professor, Emory University
ClinicalTrials.gov Identifier: NCT00399607     History of Changes
Other Study ID Numbers: 0975-2005, R01CA114456
Study First Received: November 13, 2006
Last Updated: November 22, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Emory University:
colonic neoplasms
colorectal adenoma
calcium
vitamin D

Additional relevant MeSH terms:
Polyps
Adenomatous Polyps
Pathological Conditions, Anatomical
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Calcium, Dietary
Calcium Carbonate
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents
Antacids
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014