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CLINICAL TRIALS PROFILE FOR CALCIFEDIOL

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All Clinical Trials for Calcifediol

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01574027 ↗	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.
NCT01651000 ↗	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
NCT01704079 ↗	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

Clinical Trial Conditions for Calcifediol

Condition Name

Condition Name for Calcifediol
Intervention	Trials
Vitamin D Deficiency	10
Hyperparathyroidism, Secondary	4
Secondary Hyperparathyroidism Due to Renal Causes	3

Condition MeSH

Condition MeSH for Calcifediol
Intervention	Trials
Vitamin D Deficiency	12
Hyperparathyroidism, Secondary	8
Hyperparathyroidism	8

Clinical Trial Locations for Calcifediol

Trials by Country

Trials by Country for Calcifediol
Location	Trials
United States	15
Spain	9
Indonesia	1
Iran, Islamic Republic of	1

Trials by US State

Trials by US State for Calcifediol
Location	Trials
Illinois	5
California	3
Massachusetts	2
Wisconsin	1
Virginia	1

Clinical Trial Progress for Calcifediol

Clinical Trial Phase

Clinical Trial Phase for Calcifediol
Clinical Trial Phase	Trials
Phase 4	5
Phase 3	5
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Calcifediol
Clinical Trial Phase	Trials
Recruiting	8
Completed	5
Not yet recruiting	5

Clinical Trial Sponsors for Calcifediol

Sponsor Name

Sponsor Name for Calcifediol
Sponsor	Trials
OPKO Ireland Global Holdings Ltd.	5
OPKO IP Holdings II, Inc.	2
National Cancer Institute (NCI)	1

Sponsor Type

Sponsor Type for Calcifediol
Sponsor	Trials
Other	18
Industry	12
NIH	3