Clinical trial · Interventional
Calcium and Vitamin D vs Markers of Adenomatous Polyps
Calcium, Vitamin D, and Colon Cancer Risk Biomarkers
NCT00208793CI-TRIAL-00012757CaDvMAPcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Adenomatous Polyps | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Calcium | Dietary Supplement | — | UNRESOLVED |
| Calcium and vitamin D3 combined | Dietary Supplement | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
| Vitamin D3 | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Calcium
- description
- Calcium 2,000 mg/day as calcium carbonate in two divided doses with food
- interventionNames
- Dietary Supplement: Calcium
- type
- EXPERIMENTAL
- label
- Vitamin D3
- description
- Vitamin D3 800 IU given as 400 IU twice daily with food over 6 months
- interventionNames
- Dietary Supplement: Vitamin D3
- type
- EXPERIMENTAL
- label
- Calcium and vitamin D3 combined
- description
- Calcium 2,000 mg (as calcium carbonate) + vitamin D3 800 IU given in equal divided doses twice daily with meals over 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 30 Years
- Maximum age
- 74 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (11)
- RESULTFedirko 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 19258546
- RESULTFedirko 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 19861511
- RESULTMcCullough 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 20516268
- RESULTFedirko 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 20056649
- RESULTSidelnikov 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 20332274
- RESULTAhearn 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.