Vitamin D/Calcium Polyp Prevention Study
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ClinicalTrials.gov Identifier: NCT00153816 |
Recruitment Status :
Completed
First Posted : September 12, 2005
Results First Posted : October 20, 2015
Last Update Posted : March 15, 2017
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Sponsor:
Dartmouth-Hitchcock Medical Center
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
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Tracking Information | ||||
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First Submitted Date ICMJE | September 7, 2005 | |||
First Posted Date ICMJE | September 12, 2005 | |||
Results First Submitted Date ICMJE | September 21, 2015 | |||
Results First Posted Date ICMJE | October 20, 2015 | |||
Last Update Posted Date | March 15, 2017 | |||
Actual Study Start Date ICMJE | July 2004 | |||
Actual Primary Completion Date | October 2013 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Colorectal Adenomas [ Time Frame: 1 to 10 years ] | |||
Original Primary Outcome Measures ICMJE |
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Change History | ||||
Current Secondary Outcome Measures ICMJE |
Advanced Colorectal Lesions [ Time Frame: 1 to 10 years ] Includes: adenomas >=1 cm, adenomas with high grade dysplasia, adenomas with villous features, or cancer.
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Vitamin D/Calcium Polyp Prevention Study | |||
Official Title ICMJE | Vitamin D/Calcium Polyp Prevention Study | |||
Brief Summary | Extensive experimental and observational data suggest that intake of calcium and of vitamin D exert protective effects on colorectal neoplasia. Building on their previous work, the investigators will investigate the chemopreventive effect of vitamin D in the large bowel, to study whether calcium with vitamin D is more effective than calcium alone, and to confirm their positive finding regarding calcium. The goal of this study is the development of chemopreventive combinations that will reduce risk of colorectal neoplasia sufficiently to permit the lengthening of surveillance intervals in most patients and to clarify important issues regarding the mechanisms of colorectal carcinogenesis and chemoprevention. | |||
Detailed Description | This study is a double-blind, placebo-controlled trial of vitamin D and/or calcium supplementation for the prevention of large bowel adenomas. Subjects will be recruited from 11 Study Centers in North America. Eligible subjects will have had at least one large bowel adenoma removed in the 4 months prior to study entry and no remaining polyps in the bowel after complete colonoscopic examination. Participants will be randomized in a partial 2 x 2 factorial design to vitamin D (1000 IU/day), calcium carbonate (1200 mg elemental calcium/day), both agents, or placebo only (Full Factorial randomization). Women who decline to forego calcium supplementation will be randomized only to calcium alone or to calcium plus vitamin D (Two Arm randomization). Randomization will be stratified by gender, study center of recruitment, and anticipated follow-up interval (see below), and will be conducted separately for female subjects randomized only to vitamin D. We anticipate enrolling up to 3000 participants to reach a total of up to 2400 randomized subjects. As safety measures, blood levels of calcium, creatinine, and 25-(OH)-vitamin D will be obtained at baseline and 1 year after randomization, as well as 3 years after randomization for subjects with a 5-year surveillance cycle. Every six months after randomization subjects will complete a questionnaire regarding compliance with study agents, use of medications and vitamin/mineral supplements, illnesses, hospitalizations, and dietary intake of calcium and vitamin D. The primary endpoint of the study will be new adenomas detected on follow-up colonoscopy. These examinations are scheduled to occur either 3 years or 5 years after the qualifying examination, depending on the follow-up interval recommended by each patient's endoscopist. Some patients may, for medical reasons, have a colonoscopy at a time other than 3 or 5 years after the qualifying examination. Information from these exams will be included in analyses where appropriate. In the primary analyses, the occurrence of new adenomas in the interval between randomization and the follow-up exam will be compared between subjects randomized to vitamin D (with or without calcium) versus those randomized to no vitamin D (with or without calcium), between subjects randomized to calcium (with or without vitamin D) versus those randomized to no calcium (with or without vitamin D; excluding women electing to receive calcium who therefore cannot participate in the calcium component of the study), and between those randomized to calcium plus vitamin D versus those randomized to calcium alone. In secondary analyses, we will examine the impact of baseline vitamin D levels and vitamin D receptor (VDR) polymorphisms on the vitamin D effects. Effects on advanced adenomas will also be assessed as a secondary outcome. Participants will be invited to participate in an optional Observational Follow Up phase of the study that will begin following the end of treatment. In this phase of the study, subjects will continue to be followed on an observational basis (no study treatment) with annual questionnaires until the time of a subsequent colonoscopy that is at least three years from the follow up colonoscopy at which study treatment was ended. We will examine the occurrence of new adenomas in the interval between the colonoscopy exam at the end of study treatment and the exam at the end of observational follow up period. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 Phase 3 |
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Study Design ICMJE | Allocation: Randomized Intervention Model: Factorial Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
2813 | |||
Original Enrollment ICMJE |
2000 | |||
Actual Study Completion Date ICMJE | June 2016 | |||
Actual Primary Completion Date | October 2013 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: General exclusionary criteria:
Exclusions due to derangement of calcium metabolism or indications /contraindications to study agents:
Exclusions due to intestinal or bowel problems:
Exclusions due to poor health:
Exclusions due to shipping regulations:
Drug exclusions:
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Sex/Gender ICMJE |
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Ages ICMJE | 45 Years to 75 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Puerto Rico, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00153816 | |||
Other Study ID Numbers ICMJE | 5R01CA098286-03( U.S. NIH Grant/Contract ) 5R01CA098286-10 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Dartmouth-Hitchcock Medical Center | |||
Original Responsible Party | Not Provided | |||
Current Study Sponsor ICMJE | Dartmouth-Hitchcock Medical Center | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | National Cancer Institute (NCI) | |||
Investigators ICMJE |
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PRS Account | Dartmouth-Hitchcock Medical Center | |||
Verification Date | February 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |