Calcium/Vitamin D, Biomarkers & Colon Polyp Prevention (PPS4B)
This study is enrolling participants by invitation only.
Sponsor:
Emory University
Collaborator:
Information provided by (Responsible Party):
Roberd Bostick, MD, MPH, Emory University
ClinicalTrials.gov Identifier:
NCT00399607
First received: November 13, 2006
Last updated: June 6, 2012
Last verified: June 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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, APC, β-catenin, E-cadherin, MLH1, telomerase, bcl-2, bax, TGFα, TGFβ1
| Estimated Enrollment: | 800 |
| Study Start Date: | June 2006 |
| Estimated Study Completion Date: | September 2018 |
| Estimated Primary Completion Date: | September 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
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: | R01CA114456, R01CA114456 |
| Study First Received: | November 13, 2006 |
| Last Updated: | June 6, 2012 |
| 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:
|
Colonic Polyps Polyps Adenomatous Polyps Intestinal Polyps Pathological Conditions, Anatomical Adenoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Calcium, Dietary Cholecalciferol |
Vitamin D Ergocalciferols Calcium Carbonate Vitamins Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions Antacids Molecular Mechanisms of Pharmacological Action Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on May 22, 2013