Calcium and Vitamin D vs Markers of Adenomatous Polyps
CaDvMAP
Calcium, Vitamin D, and Colon Cancer Risk Biomarkers
2 other identifiers
interventional
92
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2005
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 21, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedNovember 26, 2013
November 1, 2013
1.3 years
September 13, 2005
November 22, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Biomarkers of Risk for Colorectal Neoplasms
A panel of putative biomarkers of risk for colorectal neoplasms in biopsies of normal appearing rectal mucosa: COX-2, APC, MSH-2, MLH1, MIB-1, telomerase, p21, bcl-2, bax, bak, β-catenin, E-cadherin, TGFα, TGFβ1, calcium sensing receptor, vitamin D receptor, CYP27B1, CYP24, 8-OH-dG
6 months
Secondary Outcomes (2)
Vitamin D metabolites
6 months
Circulating inflammation markers
6 months
Study Arms (4)
Calcium
EXPERIMENTALCalcium 2,000 mg/day as calcium carbonate in two divided doses with food
Vitamin D3
EXPERIMENTALVitamin D3 800 IU given as 400 IU twice daily with food over 6 months
Calcium and vitamin D3 combined
EXPERIMENTALCalcium 2,000 mg (as calcium carbonate) + vitamin D3 800 IU given in equal divided doses twice daily with meals over 6 months
Placebo
PLACEBO COMPARATORInterventions
Calcium 2,000 mg (as calcium carbonate) + vitamin D3 800 IU given in equal divided doses twice daily with food over 6 months
Calcium 2,000 mg/day as calcium carbonate in two divided doses with meals over 6 months
Vitamin D3 800 IU given as 400 IU twice daily with food over 6 months
Eligibility Criteria
You may qualify if:
- age 30-74
- adenomatous colon polyp within past 3 years
- general good health with life expectancy of at least 2 years
- available for 8 months and able to come for clinic visits
You may not qualify if:
- cancer within 5 years
- active major disease
- renal impairment
- history of kidney stones
- significant dietary change or weight loss within past 6 months
- unable to forego usual calcium or vitamin D use during study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Emory Universitylead
- National Institutes of Health (NIH)collaborator
- National Cancer Institute (NCI)collaborator
Study Sites (1)
The Emory Clinic, Division of Digestive Diseases
Atlanta, Georgia, 30322, United States
Related Publications (11)
Fedirko V, Bostick RM, Flanders WD, Long Q, Shaukat A, Rutherford RE, Daniel CR, Cohen V, Dash C. Effects of vitamin D and calcium supplementation on markers of apoptosis in normal colon mucosa: a randomized, double-blind, placebo-controlled clinical trial. Cancer Prev Res (Phila). 2009 Mar;2(3):213-23. doi: 10.1158/1940-6207.CAPR-08-0157. Epub 2009 Mar 3.
PMID: 19258546RESULTFedirko V, Bostick RM, Flanders WD, Long Q, Sidelnikov E, Shaukat A, Daniel CR, Rutherford RE, Woodard JJ. Effects of vitamin d and calcium on proliferation and differentiation in normal colon mucosa: a randomized clinical trial. Cancer Epidemiol Biomarkers Prev. 2009 Nov;18(11):2933-41. doi: 10.1158/1055-9965.EPI-09-0239. Epub 2009 Oct 27.
PMID: 19861511RESULTMcCullough ML, Bostick RM, Daniel CR, Flanders WD, Shaukat A, Davison J, Rangaswamy U, Hollis BW. Vitamin D status and impact of vitamin D3 and/or calcium supplementation in a randomized pilot study in the Southeastern United States. J Am Coll Nutr. 2009 Dec;28(6):678-86. doi: 10.1080/07315724.2009.10719801.
PMID: 20516268RESULTFedirko V, Bostick RM, Long Q, Flanders WD, McCullough ML, Sidelnikov E, Daniel CR, Rutherford RE, Shaukat A. Effects of supplemental vitamin D and calcium on oxidative DNA damage marker in normal colorectal mucosa: a randomized clinical trial. Cancer Epidemiol Biomarkers Prev. 2010 Jan;19(1):280-91. doi: 10.1158/1055-9965.EPI-09-0448.
PMID: 20056649RESULTSidelnikov E, Bostick RM, Flanders WD, Long Q, Fedirko V, Shaukat A, Daniel CR, Rutherford RE. Effects of calcium and vitamin D on MLH1 and MSH2 expression in rectal mucosa of sporadic colorectal adenoma patients. Cancer Epidemiol Biomarkers Prev. 2010 Apr;19(4):1022-32. doi: 10.1158/1055-9965.EPI-09-0526. Epub 2010 Mar 23.
PMID: 20332274RESULTAhearn TU, McCullough ML, Flanders WD, Long Q, Sidelnikov E, Fedirko V, Daniel CR, Rutherford RE, Shaukat A, Bostick RM. A randomized clinical trial of the effects of supplemental calcium and vitamin D3 on markers of their metabolism in normal mucosa of colorectal adenoma patients. Cancer Res. 2011 Jan 15;71(2):413-23. doi: 10.1158/0008-5472.CAN-10-1560. Epub 2010 Nov 17.
PMID: 21084270RESULTHopkins MH, Owen J, Ahearn T, Fedirko V, Flanders WD, Jones DP, Bostick RM. Effects of supplemental vitamin D and calcium on biomarkers of inflammation in colorectal adenoma patients: a randomized, controlled clinical trial. Cancer Prev Res (Phila). 2011 Oct;4(10):1645-54. doi: 10.1158/1940-6207.CAPR-11-0105. Epub 2011 Jun 30.
PMID: 21724580RESULTChai W, Bostick RM, Ahearn TU, Franke AA, Custer LJ, Cooney RV. Effects of vitamin D3 and calcium supplementation on serum levels of tocopherols, retinol, and specific vitamin D metabolites. Nutr Cancer. 2012;64(1):57-64. doi: 10.1080/01635581.2012.630552. Epub 2011 Dec 9.
PMID: 22149065RESULTAhearn TU, Shaukat A, Flanders WD, Rutherford RE, Bostick RM. A randomized clinical trial of the effects of supplemental calcium and vitamin D3 on the APC/beta-catenin pathway in the normal mucosa of colorectal adenoma patients. Cancer Prev Res (Phila). 2012 Oct;5(10):1247-56. doi: 10.1158/1940-6207.CAPR-12-0292. Epub 2012 Sep 10.
PMID: 22964475RESULTHopkins MH, Flanders WD, Bostick RM. Associations of circulating inflammatory biomarkers with risk factors for colorectal cancer in colorectal adenoma patients. Biomark Insights. 2012;7:143-50. doi: 10.4137/BMI.S10092. Epub 2012 Nov 5.
PMID: 23170065RESULTTu H, Flanders WD, Ahearn TU, Daniel CR, Gonzalez-Feliciano AG, Long Q, Rutherford RE, Bostick RM. Effects of calcium and vitamin D3 on transforming growth factors in rectal mucosa of sporadic colorectal adenoma patients: a randomized controlled trial. Mol Carcinog. 2015 Apr;54(4):270-80. doi: 10.1002/mc.22096. Epub 2013 Oct 26.
PMID: 24166893DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Roberd M Bostick, MD, MPH
Emory University, Rollins School of Public Health & Winship Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 21, 2005
Study Start
May 1, 2005
Primary Completion
September 1, 2006
Study Completion
February 1, 2013
Last Updated
November 26, 2013
Record last verified: 2013-11