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Generated: December 9, 2018

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CLINICAL TRIALS PROFILE FOR CALCIFEDIOL

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Clinical Trials for Calcifediol

Trial ID Title Status Sponsor Phase Summary
NCT01574027 Efficacy of Vitamin D in Colorectal Cancer Chemoprevention Completed University of Illinois at Chicago Phase 2 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 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 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
NCT01939977 Efficacy and Safety of Paricalcitol in the Reduction of Secondary Hyperparathyroidism After Kidney Transplantation. Active, not recruiting AbbVie Phase 4 The purpose of this study is to demonstrate the superiority of paricalcitol treatment at early renal post-transplantation (M6) in the control of iPTH (Intact parathyroid hormone) compared to the use of vitamin D nutritional supplements (calcifediol) in patients with renal transplantation.
NCT01939977 Efficacy and Safety of Paricalcitol in the Reduction of Secondary Hyperparathyroidism After Kidney Transplantation. Active, not recruiting Effice Servicios Para la Investigacion S.L. Phase 4 The purpose of this study is to demonstrate the superiority of paricalcitol treatment at early renal post-transplantation (M6) in the control of iPTH (Intact parathyroid hormone) compared to the use of vitamin D nutritional supplements (calcifediol) in patients with renal transplantation.
NCT01939977 Efficacy and Safety of Paricalcitol in the Reduction of Secondary Hyperparathyroidism After Kidney Transplantation. Active, not recruiting Fundación Senefro Phase 4 The purpose of this study is to demonstrate the superiority of paricalcitol treatment at early renal post-transplantation (M6) in the control of iPTH (Intact parathyroid hormone) compared to the use of vitamin D nutritional supplements (calcifediol) in patients with renal transplantation.
NCT02091219 Effects of Vitamin D3 Versus 25OHD3 on Mineral Metabolism and Immune Function Active, not recruiting National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) Phase 0 The purpose of this study is to compare the effects of two different forms of vitamin D supplements (vitamin D3 and 25-hyrdroxyvitamin D3 [25(OH)D3]) on vitamin D levels in the blood, and on markers of skeletal and immune health. This study is designed as a pilot study. A multi-ethnic cohort of 48 patients will be included (12 Caucasian, 12 African American, 12 Hispanic/Latino, 12 Asian/Asian American). Potential study candidates will undergo a screening visit during which a medical history will be taken, a physical exam performed, a dietary questionnaire administered, and blood collected. The purpose of the screening visit is to identify vitamin D-deficient (25-hydroxyvitamin D <20 ng/ml) individuals who are candidates for vitamin D supplementation. Eligible patients will then be randomly assigned to receive either vitamin D3 (2400 IU/day) or 25(OH)D3 (20 mcg/day) for 16 weeks. After initiating supplementation, study patients will return for follow-up visits at weeks 4, 8, and 16. At each visit, blood will be collected to assess vitamin D levels in the blood, as well as markers of skeletal and immune function. Participation in this study will therefore involve a total of 5 visits (1 screening visit, 1 randomization visit during which participants will receive their study supplements, 3 follow-up visits). After all data is collected, changes in vitamin D levels in the blood following supplementation with either vitamin D3 versus 25(OH)D3 will be determined, and correlated to markers of calcium balance and immune function. Knowledge gained from this study may have a significant impact on how vitamin D status is defined, and how vitamin D repletion is administered.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Calcifediol

Condition Name

Condition Name for Calcifediol
Intervention Trials
Vitamin D Deficiency 9
Hyperparathyroidism, Secondary 4
Chronic Kidney Disease 3
Secondary Hyperparathyroidism Due to Renal Causes 3
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Condition MeSH

Condition MeSH for Calcifediol
Intervention Trials
Vitamin D Deficiency 11
Hyperparathyroidism, Secondary 7
Hyperparathyroidism 7
Neoplasm Metastasis 6
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Clinical Trial Locations for Calcifediol

Trials by Country

Trials by Country for Calcifediol
Location Trials
United States 14
Spain 8
Iran, Islamic Republic of 1
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Trials by US State

Trials by US State for Calcifediol
Location Trials
Illinois 5
Massachusetts 2
California 2
Wisconsin 1
Virginia 1
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Clinical Trial Progress for Calcifediol

Clinical Trial Phase

Clinical Trial Phase for Calcifediol
Clinical Trial Phase Trials
Phase 4 5
Phase 3 4
Phase 2 4
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Clinical Trial Status

Clinical Trial Status for Calcifediol
Clinical Trial Phase Trials
Recruiting 6
Completed 5
Active, not recruiting 3
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Clinical Trial Sponsors for Calcifediol

Sponsor Name

Sponsor Name for Calcifediol
Sponsor Trials
OPKO Ireland Global Holdings Ltd. 4
OPKO IP Holdings II, Inc. 2
Spanish Society of Cardiology 1
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Sponsor Type

Sponsor Type for Calcifediol
Sponsor Trials
Other 13
Industry 8
NIH 2
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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Baxter
UBS
Daiichi Sankyo
Chinese Patent Office
AstraZeneca
Medtronic
Cantor Fitzgerald
US Department of Justice

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