Vitamin D/Calcium Polyp Prevention Study
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
10 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 modified 2 x
2 factorial design to vitamin D (1000 IU/day), calcium carbonate (1200 mg elemental
calcium/day), both agents, or placebo only. Women who decline to forego calcium
supplementation will be randomized only to calcium alone or to calcium plus vitamin D.
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 about 2500 participants to reach a
total of approximately 2000 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
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 neoplastic polyps 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 placebo (with
or without calcium), between subjects randomized to calcium (with or without vitamin D)
versus those randomized to placebo (with or without vitamin D, excluding women electing to
receive calcium and 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 effect of calcium plus vitamin D versus vitamin
D alone, and 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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Colorectal adenomas
1 to 5 years
No
John A. Baron, MD
Principal Investigator
Dartmouth-Hitchcock Medical Center
United States: Food and Drug Administration
5 R01 CA098286-03
NCT00153816
July 2004
December 2017
Name | Location |
---|---|
University of Iowa | Iowa City, Iowa 52242 |
Cleveland Clinic Foundation | Cleveland, Ohio 44195 |
University of Colorado | Denver, Colorado 80217 |
University of Minnesota | Minneapolis, Minnesota 55455 |
University of North Carolina | Chapel Hill, North Carolina 27599 |
Emory University | Atlanta, Georgia 30322 |
Dartmouth Hitchcock Medical Center | Lebanon, New Hampshire 03756 |
University of Southern California | Los Angeles, California 90033 |
University of Texas | Houston, Texas 77225 |
University of South Carolina | Columbia, South Carolina 29203 |