Efficacy of Vitamin D in Colorectal Cancer Chemoprevention
Completed
University of Illinois at Chicago
Phase 2
2008-04-01
Vitamin D's ability to prevent colorectal cancer (CRC) has been suspected for nearly 30
years, but has never been directly studied in humans. The biologically active version of
vitamin D, 1,25(OH)2D3, cannot be readily used in humans because of its tendency to cause
serum calcium levels to rise. In contrast, 25(OH)D3 (ie calcifediol) does not have this side
effect. The investigators previous research suggests that the enzyme necessary to convert
25(OH)D3 (calcifediol) into active 1,25(OH)D3 is present in cells lining the large intestine
(colon).
Aberrant crypt foci (ACF) are very small (ie microscopic) collections of abnormally shaped
cells that are a commonly used marker of CRC risk. Screening colonoscopy at UIC routinely
uses methods that allow ACF counting to be done as a part of standard practice. ACF's are not
fixed, like polyps or cancers, but can disappear as a person's risk for developing CRC
decreases.
The investigators propose giving patient's with 10 or more ACF's 25(OH)D3 (calcifediol) or
placebo, and determining if there is a drug-dependant decrease in ACF number. The primary
objective is to determine whether 25(OH)D3 (calcifediol) supplementation, compared to
placebo, causes significant reduction of ACF number from baseline levels. The primary
endpoint will be change in ACF number.
Safety and Efficacy of CTAP101 to Treat Secondary Hyperparathyroidism in Stage 3 or 4 CKD and Vitamin D Insufficiency
Completed
OPKO IP Holdings II, Inc.
Phase 3
2012-09-01
This study will evaluate the efficacy of CTAP101 Capsules versus placebo in reducing intact
parathyroid hormone (iPTH) by at least 30% from pretreatment baseline; safety and
tolerability of CTAP101 will also be evaluated
Safety and Efficacy of CTAP101 to Treat Secondary Hyperparathyroidism in Stage 3 or 4 CKD and Vitamin D Insufficiency
Completed
OPKO IP Holdings II, Inc.
Phase 3
2012-11-01
This study will evaluate the efficacy of CTAP101 Capsules versus placebo in reducing intact
parathyroid hormone (iPTH) by at least 30% from pretreatment baseline; safety and
tolerability of CTAP101 will also be evaluated
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