Colorectal Adenomatous PolypsPhase 2CaDvMAPNCT00208793
Calcium and Vitamin D vs Markers of Adenomatous Polyps
A Phase 2 study testing Calcium and vitamin D3 combined, Calcium and Vitamin D3 in people with Colorectal Adenomatous Polyps, run by Emory University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 74 years
- Conditions the study is for
- Colorectal Adenomatous Polyps
- What is being tested?
- Calcium and vitamin D3 combined, Calcium and Vitamin D3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- May 2005to Feb 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Emory Clinic, Division of Digestive Diseases
Atlanta, Georgia, 30322
About this study
Official title: Calcium, Vitamin D, and Colon Cancer Risk Biomarkers
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).
Read the detailed description
There is strong biologic plausibility and animal experimental evidence for protection against colorectal cancer by calcium and vitamin D, calcium significantly reduced adenoma recurrence in a large clinical trial in humans (yet the previously reported observational evidence, although generally supportive, is inconsistent), and the observational literature strongly supports protection from vitamin D. A close physiological relationship between calcium and vitamin D has long been known. Yet, other than a possible reduction of colorectal epithelial cell proliferation by calcium, the effects of calcium and vitamin D, individually or jointly, on the normal human colorectal epithelium remain unknown. There have been no clinical trials involving vitamin D individually or jointly with calcium related to colorectal cancer chemoprevention in humans. There are currently no generally accepted pre-neoplastic biomarkers of risk for colorectal cancer other than the possible exception of proliferation markers that, at best, have limited usefulness as individual markers. Based on recent advances in understanding the molecular basis of colorectal cancer, we developed a panel of newer, plausible, reliable, immunohistochemically detected biomarkers that provides molecular phenotyping of the normal appearing colorectal epithelium: 1) inflammation (COX-2), 2) the expression of genes involved in the normal structure and function of the colorectal epithelium that have been found to be altered early in the two major colorectal carcinogenesis pathways (APC, MSH2, MLH1), and 3) a more complete picture of the cell cycle events in colorectal epithelial crypt cells (short and long-term proliferation: MIB-1 and telomerase; differentiation: p21; apoptosis inhibition and promotion: bcl-2, bax, and bak) that has not yet been tested in a chemoprevention trial.
To address these needs, we will conduct a preliminary, randomized, double-blind, placebo-controlled, 2 x 2 factorial chemoprevention trial (n = 88) of calcium 2,000 mg/day and vitamin D3 800 IU/day, alone and in combination vs placebo over 6 months in patients with recent removal of sporadic adenomatous colorectal polyps, to investigate their effects on the individual components and aggregate profile of our colorectal cancer risk biomarker panel. We will also examine study results stratified by NSAID use and Bsm I vitamin D receptor genotypes. The preliminary estimates of treatment effect sizes and variabilities will be used to refine the biomarker panel and study design and to calculate the needed sample size for a potential full-scale study.
We assert that using biological measurements of risk, as they have for ischemic heart disease, will result in a decline in colorectal cancer incidence and mortality. The proposed project is borne of this vision, and has intertwined missions of exploring the efficacy of two plausible and evidentially well-supported dietary agents, calcium and vitamin D, on the modulation of a plausible panel of molecular phenotypic biomarkers of risk for colorectal neoplasia.
- Conditions
- Colorectal Adenomatous Polyps
- Being tested
- Calcium and vitamin D3 combined, Placebo, Calcium, Vitamin D3
- Keywords
- colonic polyps, adenomatous polyps, colon cancer prevention, dietary supplements
- Medical subject headings
- Colonic Polyps, Adenomatous Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium and vitamin D3 combinedDietary supplement
Calcium 2,000 mg (as calcium carbonate) + vitamin D3 800 IU given in equal divided doses twice daily with food over 6 months
PlaceboDrug
Placebo
CalciumDietary supplement
Calcium 2,000 mg/day as calcium carbonate in two divided doses with meals over 6 months
Vitamin D3Dietary supplement
Vitamin D3 800 IU given as 400 IU twice daily with food over 6 months
| Study group | Role | What they receive |
|---|---|---|
| Calcium | Experimental | Calcium 2,000 mg/day as calcium carbonate in two divided doses with food Receives: Dietary Supplement: Calcium |
| Vitamin D3 | Experimental | Vitamin D3 800 IU given as 400 IU twice daily with food over 6 months Receives: Dietary Supplement: Vitamin D3 |
| Calcium and vitamin D3 combined | Experimental | Calcium 2,000 mg (as calcium carbonate) + vitamin D3 800 IU given in equal divided doses twice daily with meals over 6 months Receives: Dietary Supplement: Calcium and vitamin D3 combined |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (2)
Vitamin D metabolites
serum 25-OH-vitamin D3 and 1,25-OH-vitamin D3
Measured: 6 months
Circulating inflammation markers
serum CRP, TNF-α, IL-6, IL-1β, IL-8 and IL-10
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startMay 2005
- Primary completionSep 2006
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Colorectal Adenomatous PolypsStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Roberd Bostick, MD, MPH, Emory University
- Investigators
- Roberd M Bostick, MD, MPH, Principal investigator, Emory University, Rollins School of Public Health & Winship Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00208793
- Sponsor's protocol ID
- 0126-2004
- Other IDs
- R01CA104637
- Acronym
- CaDvMAP
- Status last verified
- Nov 2013
- First submitted
- 13 Sep 2005
- Last updated
- 26 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19258546Fedirko 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.
PubMed 19861511McCullough 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.
PubMed 20516268Fedirko 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.
PubMed 20056649Sidelnikov 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.
PubMed 20332274Ahearn 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.
PubMed 21084270Hopkins 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.
PubMed 21724580Chai 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.
PubMed 22149065Ahearn 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.
PubMed 22964475Hopkins 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.
PubMed 23170065Tu 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.
PubMed 24166893
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calcium, Vitamin D, and Colon Cancer Risk Biomarkers
- ClinicalTrials.gov ID
- NCT00208793
- Acronym / sponsor ID
- CaDvMAP / 0126-2004
- Conditions
- Colorectal Adenomatous Polyps
- Keywords
- colonic polyps, adenomatous polyps, colon cancer prevention, dietary supplements
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- May 2005
- Primary completion
- Sep 2006 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
There is strong biologic plausibility and animal experimental evidence for protection against colorectal cancer by calcium and vitamin D, calcium significantly reduced adenoma recurrence in a large clinical trial in humans (yet the previously reported observational evidence, although generally supportive, is inconsistent), and the observational literature strongly supports protection from vitamin D. A close physiological relationship between calcium and vitamin D has long been known. Yet, other than a possible reduction of colorectal epithelial cell proliferation by calcium, the effects of calcium and vitamin D, individually or jointly, on the normal human colorectal epithelium remain unknown. There have been no clinical trials involving vitamin D individually or jointly with calcium related to colorectal cancer chemoprevention in humans. There are currently no generally accepted pre-neoplastic biomarkers of risk for colorectal cancer other than the possible exception of proliferation markers that, at best, have limited usefulness as individual markers. Based on recent advances in understanding the molecular basis of colorectal cancer, we developed a panel of newer, plausible, reliable, immunohistochemically detected biomarkers that provides molecular phenotyping of the normal appearing colorectal epithelium: 1) inflammation (COX-2), 2) the expression of genes involved in the normal structure and function of the colorectal epithelium that have been found to be altered early in the two major colorectal carcinogenesis pathways (APC, MSH2, MLH1), and 3) a more complete picture of the cell cycle events in colorectal epithelial crypt cells (short and long-term proliferation: MIB-1 and telomerase; differentiation: p21; apoptosis inhibition and promotion: bcl-2, bax, and bak) that has not yet been tested in a chemoprevention trial.
To address these needs, we will conduct a preliminary, randomized, double-blind, placebo-controlled, 2 x 2 factorial chemoprevention trial (n = 88) of calcium 2,000 mg/day and vitamin D3 800 IU/day, alone and in combination vs placebo over 6 months in patients with recent removal of sporadic adenomatous colorectal polyps, to investigate their effects on the individual components and aggregate profile of our colorectal cancer risk biomarker panel. We will also examine study results stratified by NSAID use and Bsm I vitamin D receptor genotypes. The preliminary estimates of treatment effect sizes and variabilities will be used to refine the biomarker panel and study design and to calculate the needed sample size for a potential full-scale study.
We assert that using biological measurements of risk, as they have for ischemic heart disease, will result in a decline in colorectal cancer incidence and mortality. The proposed project is borne of this vision, and has intertwined missions of exploring the efficacy of two plausible and evidentially well-supported dietary agents, calcium and vitamin D, on the modulation of a plausible panel of molecular phenotypic biomarkers of risk for colorectal neoplasia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Calcium | Experimental | Dietary Supplement: CalciumCalcium 2,000 mg/day as calcium carbonate in two divided doses with food |
| Vitamin D3 | Experimental | Dietary Supplement: Vitamin D3Vitamin D3 800 IU given as 400 IU twice daily with food over 6 months |
| Calcium and vitamin D3 combined | Experimental | Dietary Supplement: Calcium and vitamin D3 combinedCalcium 2,000 mg (as calcium carbonate) + vitamin D3 800 IU given in equal divided doses twice daily with meals over 6 months |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 30 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- cancer within 5 years
- active major disease
- renal impairment
- history of kidney stones
- significant dietary change or weight loss within past 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calcium and vitamin D3 combinedCalcium 2,000 mg (as calcium carbonate) + vitamin D3 800 IU given in equal divided doses twice daily with food over 6 months | Dietary supplement | Calcium and vitamin D3 combined |
| PlaceboPlacebo | Drug | Placebo |
| CalciumCalcium 2,000 mg/day as calcium carbonate in two divided doses with meals over 6 months | Dietary supplement | Calcium |
| Vitamin D3Vitamin D3 800 IU given as 400 IU twice daily with food over 6 months | Dietary supplement | Vitamin D3 |
Primary outcome
Biomarkers of Risk for Colorectal Neoplasms
Time frame: 6 months
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
2 secondary outcomes
Vitamin D metabolites
Time frame: 6 months
Circulating inflammation markers
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2013.
- Results publication: PubMed 19258546Fedirko 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.
- Results publication: PubMed 19861511Fedirko 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.
- Results publication: PubMed 20516268McCullough 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.
- Results publication: PubMed 20056649Fedirko 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.
- Results publication: PubMed 20332274Sidelnikov 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.
- Results publication: PubMed 21084270Ahearn 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.
- Results publication: PubMed 21724580Hopkins 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.
- Results publication: PubMed 22149065Chai 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.
- Results publication: PubMed 22964475Ahearn 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.
- Results publication: PubMed 23170065Hopkins 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.
- Derived from this study: PubMed 24166893Tu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roberd M Bostick, MD, MPH principal investigator
Emory University, Rollins School of Public Health & Winship Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Calcium and vitamin D3 combined, Calcium and Vitamin D3 in people with Colorectal Adenomatous Polyps, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomarkers of Risk for Colorectal Neoplasms (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00208793, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2013.