Clinical Trials

Numerous clinical trials spanning Early Phase 1 through Phase 4 evaluate calcitriol across diverse therapeutic areas, including secondary hyperparathyroidism, postmenopausal osteoporosis, prostate cancer, pulmonary sarcoidosis, pseudohypoparathyroidism, and IgA nephropathy. Sponsored by academic institutions and pharmaceutical companies, these protocols encompass active, completed, enrolling by invitation, and terminated recruitment statuses. Notable efforts range from Phase 2 combination therapy trials in oncology to Phase 4 investigations in renal conditions.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07640347 NOT_YET_RECRUITING
Lowering Parathyroid Hormone Level in Patients on Hemodioalysis
Chittagong Medical College
 2026-07-05
NCT06288451 ACTIVE_NOT_RECRUITING
Kidney Failure, Chronic; Chronic Kidney Disease-Mineral and Bone Disorder
University of Washington
 2024-03-11 PHASE2
NCT07763977 ENROLLING_BY_INVITATION
Obsessive Compulsive Disorder (OCD)
Guangdong Provincial People's Hospital
 2024-08-06
NCT07670611 RECRUITING
Cholestatic Liver Disease; Chronic Liver Disease (CLD); Vitamin D Deficiency; Children
Chulalongkorn University
 2026-04-28 PHASE4
NCT07299552 NOT_YET_RECRUITING
Malocclusions
Hospital Universiti Sains Malaysia
 2025-12-30
NCT07200349 NOT_YET_RECRUITING
Maxillary Canine Retraction; Local Calcitriol Delivery; Orthodontic Tooth Movement
Al-Azhar University
 2025-11-01
NCT03249012 UNKNOWN
Hypoparathyroidism Postprocedural; Quality of Life
CHU de Quebec-Universite Laval
 2017-09-01
NCT02859896 TERMINATED
Secondary Hyperparathyroidism-Chronic Kidney Disease
Sanofi
 2017-01-19 PHASE3
NCT05902078 UNKNOWN
Low Bone Mineral Density; Postmenopausal Osteoporosis
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
 2023-09-27 PHASE4
NCT03748966 COMPLETED
X-linked Hypophosphatemia; Hypophosphatemic Rickets; Hypophosphatemic Rickets, X-Linked Dominant
Massachusetts General Hospital
 2019-03-28 EARLY_PHASE1
NCT06261905 COMPLETED
Opioid Use Disorder
Yale University
 2024-03-13 PHASE1
NCT05252884 COMPLETED
Thyroid Cancer; Goiter; Thyroiditis; Hyperthyroidism
Centro de Excelencia en Enfermedades de Cabeza y Cuello
 2022-06-30
NCT06169397 Enrolling by invitation
Pulmonary Sarcoidosis
Xentria Inc.
 2024-03-01 Phase 2
NCT04967469 COMPLETED
End Stage Renal Disease
Department of Medical Services Ministry of Public Health of Thailand
 2020-09-01
NCT03103750 COMPLETED
ADHD
Yale University
 2017-08-15 PHASE1
NCT05298163 UNKNOWN
Diabetic Kidney Disease
Indonesia University
 2022-04
NCT04801303 COMPLETED
Friedreich Ataxia
Berta Alemany
 2021-08-25 PHASE4
NCT05415254 UNKNOWN
COVID-19; Vitamin D Deficiency
RenJi Hospital
 2022-06-12
NCT05560919 COMPLETED
Mild to Moderate Anterior Mandibular Segment Crowdind
Latakia University
 2021-09-20 PHASE2; PHASE3
NCT03820518 UNKNOWN
X-linked Hypophosphatemia
Peking Union Medical College Hospital
 2017-01-01 PHASE4
NCT03563235 UNKNOWN
Postmenopausal Osteoporoses
Fujian Academy of Traditional Chinese Medicine
 2019-09-01 EARLY_PHASE1
NCT05765617 COMPLETED
COVID-19
Universitas Sebelas Maret
 2021-07-01 PHASE2
NCT01868750 COMPLETED
Thyroid Nodules; Hypocalcemia
David Shonka, MD
 2013-05 PHASE2
NCT04286529 TERMINATED
Pre-Diabetic
Mayo Clinic
 2020-10-01 PHASE1
NCT05202496 COMPLETED
Angle Class I
Postgraduate Institute of Dental Sciences Rohtak
 2019-11-20
NCT04386811 TERMINATED
ADHD
Yale University
 2020-08-05 PHASE1
NCT02962102 COMPLETED
Critically Ill; Acute Kidney Injury
David Leaf
 2017-04-03 PHASE2
NCT04551170 Recruiting
Pseudohypoparathyroidism|Albright Hereditary Osteodystrophy|Pseudohypoparathyroidism Type 1a
Vanderbilt University Medical Center
 2020-07-13 Phase 2
NCT04826133 TERMINATED
Cocaine Use Disorder
Yale University
 2019-03-27 EARLY_PHASE1
NCT03869398 COMPLETED
Hypocalcemia; Thyroid Diseases
Lahey Clinic
 2017-08-01
NCT03216564 UNKNOWN
Diabetic Nephropathies
Hamad Medical Corporation
 2017-05-10 PHASE3
NCT04637360 COMPLETED
Hyperparathyroidism; Secondary, Renal
Min-Sheng General Hospital
 2018-01-01
NCT02061384 COMPLETED
Male Infertility; Klinefelter's Syndrome; Y-chromosome Microdeletions
University of Washington
 2014-08 PHASE2
NCT03029429 Recruiting
Pseudohypoparathyroidism|Albright Hereditary Osteodystrophy
Vanderbilt University Medical Center|Harvard University
 2018-09-01 Phase 2
NCT01293682 COMPLETED
Breast Cancer
University of Rochester
 2010-11 PHASE2
NCT02125279 COMPLETED
Psoriasis Vulgaris
Galderma R&D
 2014-05 PHASE4
NCT03261336 TERMINATED
Castration-resistant Prostate Cancer
Donald Trump, MD
 2017-01-06 PHASE2
NCT00904033 COMPLETED
Breast Neoplasms; Bone and Bones
University of Rochester
 2008-12-01 PHASE2
NCT04643821 COMPLETED
HIE - Perinatal Hypoxic - Ischemic Encephalopathy
Medical University of South Carolina
 2015-01-01 EARLY_PHASE1
NCT00690924 COMPLETED
Lung Cancer; Precancerous Condition; Tobacco Use Disorder
Roswell Park Cancer Institute
 2008-07-17
NCT01588522 COMPLETED
Chemotherapy-Induced Alopecia
BPGbio
 2012-09-17 PHASE1
NCT03140449 COMPLETED
Facial Angiofibroma
National Taiwan University Hospital
 2013-09-05 PHASE3
NCT02224144 COMPLETED
End Stage Renal Disease; Kidney Transplantation; Bone Loss; Fractures; Vascular Calcifications
Columbia University
 2014-08-18 PHASE2
NCT00536991 TERMINATED
Prostate Adenocarcinoma; Recurrent Prostate Carcinoma; Stage III Prostate Cancer; Stage IV Prostate Cancer
Roswell Park Cancer Institute
 2006-10 PHASE1; PHASE2
NCT01237028 COMPLETED
IgA Nephropathy
Yonsei University
 2011-03
NCT01506947 COMPLETED
Moderate to Severe Secondary Hyperparathyroidism; Stage 5 Chronic Kidney Diseases
AbbVie (prior sponsor, Abbott)
 2012-05-10 PHASE4
NCT01561222 UNKNOWN
Chronic Kidney Disease Stage 1; Chronic Kidney Disease Stage 2
Taixing People's Hospital
 2015-07 PHASE4
NCT01635062 COMPLETED
Type 2 Diabetes; Obesity
Brigham and Women's Hospital
 2012-09
NCT00953849 COMPLETED
Mouth Neoplasms
VA Office of Research and Development
 2009-11 PHASE1; PHASE2
NCT01766440 COMPLETED
Plaque Psoriasis
Galderma R&D
 2013-03 PHASE4
NCT02186665 COMPLETED
Plaque Psoriasis
Galderma R&D
 2014-07 PHASE4
NCT02410005 TERMINATED
Diabetic Nephropathies
Weill Cornell Medical College in Qatar
 2014-10 PHASE2; PHASE3
NCT01384539 COMPLETED
Arterial Dysfunction; Chronic Kidney Disease
University of Colorado, Denver
 2011-07 PHASE3
NCT01988116 COMPLETED
Chronic Kidney Disease; Anemia of Chronic Disease
University of Alabama at Birmingham
 2013-10 EARLY_PHASE1
NCT01093092 TERMINATED
Adult Solid Neoplasm
Roswell Park Cancer Institute
 2011-09 PHASE1
NCT02282813 COMPLETED
Chronic Kidney Disease; Hyperparathyroidism, Secondary; Vitamin D Deficiency
OPKO Health, Inc.
 2013-04 PHASE3
NCT01820832 UNKNOWN
Chronic Kidney Disease; Proteinuria
Huashan Hospital
 2013-03 PHASE4
NCT01026363 WITHDRAWN
Chronic Kidney Disease; Vitamin D Deficiency
Massachusetts General Hospital
 2009-12
NCT01673204 UNKNOWN
Diabetic Nephropathy
Seoul National University Hospital
 2012-10 PHASE4
NCT00001304 COMPLETED
Hypoparathyroidism
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
 1991-10 PHASE2
NCT01689441 COMPLETED
Severe Sepsis or Septic Shock
Brigham and Women's Hospital
 2013-02 PHASE2
NCT01725113 TERMINATED
Kidney Failure; Secondary Hyperparathyroidism; Hyperphosphatemia; Hypercalcemia
Winthrop University Hospital
 2012-11 PHASE4
NCT01863641 UNKNOWN
Systemic Lupus Erythematosus
Guilan University of Medical Sciences
 2013-04 PHASE2
NCT00752102 COMPLETED
Chronic Kidney Disease; Vitamin D Deficiency; Coronary Calcification; Disorders of Calcium and Bone Metabolism
Joslin Diabetes Center
 2008-09 PHASE4
NCT00926315 UNKNOWN
Breast Neoplasms; Postmenopausal Disorder
University of Sao Paulo General Hospital
 2007-07
NCT00823303 COMPLETED
Secondary Hyperparathyroidism; Chronic Kidney Disease
Washington University School of Medicine
 2009-02 PHASE4
NCT01220843 COMPLETED
Chronic Renal Failure
Centre Hospitalier Universitaire, Amiens
 2010-10 PHASE3
NCT02047799 COMPLETED
High Blood Pressure
Universidad de Colima
 2013-04 PHASE2
NCT01765010 UNKNOWN
Osteoporosis
Seoul National University Hospital
 2013-01 PHASE4
NCT01358045 COMPLETED
Basal Cell Carcinoma
Maastricht University Medical Center
 2011-11 PHASE2
NCT01350934 COMPLETED
Osteoporosis, Postmenopausal
Organon and Co
 2011-06-19 PHASE4
NCT01748396 COMPLETED
Chronic Kidney Disease Stage 3
Seoul National University Hospital
 2012-07 PHASE4
NCT01512862 UNKNOWN
Proteinuria
Seoul National University Hospital
 2012-01 PHASE4
NCT01222234 COMPLETED
Chronic Kidney Disease (CKD); End-stage Renal Disease (ESRD)
University of Kansas Medical Center
 2010-10
NCT00301067 COMPLETED
Metastatic Melanoma
Northwestern University
 2005-01-30 PHASE1; PHASE2
NCT00459563 WITHDRAWN
Hypertension
Atlanta VA Medical Center
 2007-03
NCT00794547 TERMINATED
Non Small Cell Lung Cancer
University of Michigan Rogel Cancer Center
 2008-12 PHASE1; PHASE2
NCT01039181 UNKNOWN
Advanced Intrahepatic Cholangiocarcinoma
National Science and Technology Development Agency, Thailand
 2010-01 PHASE2
NCT00118066 TERMINATED
Precancerous/Nonmalignant Condition; Prostate Cancer
Rutgers, The State University of New Jersey
 2004-05 PHASE2
NCT01235728 COMPLETED
Psoriasis; Plaque Psoriasis
Merck Sharp & Dohme LLC
 2010-11-01 PHASE1
NCT01768351 COMPLETED
Anemia; Chronic Kidney Disease
Federico II University
 2010-10 PHASE4
NCT00486512 TERMINATED
Adenomatous Polyps
Colotech A/S
 2007-06 PHASE3
NCT00957879 COMPLETED
Vitamin D Deficiency
Massachusetts General Hospital
 2009-05
NCT01388517 COMPLETED
Pityriasis Alba
Universidad Autonoma de San Luis Potosí
 2008-01 PHASE4
NCT00862693 UNKNOWN
Glomerulonephritis; Autoimmune Diseases
Peking University First Hospital
 2009-03 PHASE4
NCT00712205 UNKNOWN
Asthma
Kantonsspital Baselland Bruderholz
 2008-08 PHASE4
NCT00524589 TERMINATED
Prostate Cancer
Roswell Park Cancer Institute
 2006-04 PHASE2
NCT00623974 TERMINATED
Hypocalcemia
M.D. Anderson Cancer Center
 2008-05 PHASE2
NCT01265615 COMPLETED
Cardiorenal Syndrome; Chronic Allograft Nephropathy
Ural State Medical University
 2009-10 PHASE4
NCT00988637 COMPLETED
Plaque Psoriasis
Galderma R&D
 2009-10 PHASE4
NCT00084864 TERMINATED
Prostate Cancer
Roswell Park Cancer Institute
 2002-09 PHASE2
NCT01205880 COMPLETED
Psoriasis
Emer, Jason, M.D.
 2009-12 PHASE4
NCT00800358 COMPLETED
Hyperparathyroidism; Kidney Disease
Penang Hospital, Malaysia
 2008-11
NCT00678756 UNKNOWN
Psoriasis Vulgaris
Technische Universität Dresden
 2008-03 PHASE2
NCT00419666 COMPLETED
Chronic Plaque Psoriasis
Galderma R&D
 2006-08-01 PHASE2
NCT00508898 WITHDRAWN
Systemic Lupus Erythematosus; Nephritis; Proteinuria
Chinese University of Hong Kong
 2008-05 PHASE4
NCT01115543 COMPLETED
Secondary Hyperparathyroidism; End Stage Renal Disease
Mahidol University
 2008-08 PHASE4
NCT00427804 COMPLETED
Rheumatoid Arthritis; Crohn's Disease
Atlanta VA Medical Center
 2007-01
NCT00925704 COMPLETED
Healthy
Shire
 2009-06-01 PHASE1
NCT00664430 TERMINATED
Secondary Hyperparathyroidism; Dialysis
Abbott
 2009-01 PHASE4
NCT00298545 COMPLETED
Colorectal Polyps; Colorectal Adenoma; Adenocarcinoma
Rockefeller University
 2005-11 PHASE1
NCT00763555 COMPLETED
Psoriasis
Galderma R&D
 2008-09 PHASE2
NCT00658788 COMPLETED
Psoriasis
Galderma R&D
 2008-03 PHASE3
NCT00960635 COMPLETED
Type 1 Diabetes
Institut fur Diabetesforschung, Munich, Germany
 2001-06 PHASE2
NCT00585442 TERMINATED
Hypertension; Vitamin D Deficiency
University of Utah
 2007-05 EARLY_PHASE1
NCT00482157 WITHDRAWN
Prostatic Neoplasms; Prostate Cancer
Stanford University
 2007-02
NCT00319761 COMPLETED
IGA Nephropathy
Chinese University of Hong Kong
 2006-05 PHASE4
NCT00030069 COMPLETED
Myelodysplastic Syndromes
University of Pittsburgh
 2001-09 PHASE2
NCT00383487 TERMINATED
Prostatic Neoplasms; Prostate Cancer
Stanford University
 2005-03 PHASE2
NCT00084708 COMPLETED
Unspecified Adult Solid Tumor, Protocol Specific
Roswell Park Cancer Institute
 2002-11 PHASE1
NCT00238199 COMPLETED
Pancreatic Cancer
OHSU Knight Cancer Institute
 2002-06 PHASE2
NCT00182741 COMPLETED
Prostate Cancer
OHSU Knight Cancer Institute
 2004-09 PHASE2
NCT00017576 COMPLETED
Prostate Cancer
OHSU Knight Cancer Institute
 2000-12 PHASE2
NCT00238225 COMPLETED
Unspecified Adult Solid Tumor, Protocol Specific
Roswell Park Cancer Institute
 2004-11 PHASE1
NCT00054522 COMPLETED
Prostate Cancer
Roswell Park Cancer Institute
 2002-04 PHASE2
NCT00009802 COMPLETED
Unspecified Adult Solid Tumor, Protocol Specific
University of Pittsburgh
 1998-06 PHASE1
NCT00004928 COMPLETED
Prostate Cancer
Memorial Sloan Kettering Cancer Center
 1999-10 PHASE1
NCT00008086 COMPLETED
Brain and Central Nervous System Tumors; Unspecified Adult Solid Tumor, Protocol Specific
University of Pittsburgh
 1996-01 PHASE1
NCT01969656 COMPLETED
Postmenopausal Osteoporosis, Multiple Sites
Deltanoid Pharmaceuticals
 PHASE1
NCT00601328 COMPLETED
Secondary Hyperparathyroidism; Hypocalcemia
Roxane Laboratories
 2003-07
NCT00004043 COMPLETED
Prostate Cancer
OHSU Knight Cancer Institute
 1999-02 PHASE2
NCT00010231 COMPLETED
Prostate Cancer
University of Pittsburgh
 1999-06 PHASE1
NCT00000412 COMPLETED
Osteoporosis; Cardiac Transplantation
Columbia University
 1997-09 PHASE3
NCT00004402 COMPLETED
Osteopetrosis
FDA Office of Orphan Products Development
 1999-11 PHASE3
NCT00287170 COMPLETED
Crohn's Disease
Teva GTC
 2006-07 PHASE1; PHASE2
NCT00006275 COMPLETED
Psoriasis
National Center for Research Resources (NCRR)
 2000-07
NCT00055263 COMPLETED
Neoplasms
Novacea
 2002-03 PHASE1
NCT00004468 WITHDRAWN
Psoriasis
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 1998-10
NCT00285675 UNKNOWN
Androgen Independent Prostate Cancer (AIPC); Non Small Cell Lung Cancer (NSCLC)
Novacea
 2006-04 PHASE2
NCT01120119 COMPLETED
Diabetes Mellitus, Type 1
Campus Bio-Medico University
 PHASE2
NCT00536770 SUSPENDED
Pancreatic Cancer
Novacea
 2007-09 PHASE2
NCT00273338 TERMINATED
Prostate Cancer
Novacea
 2006-01 PHASE3
NCT00004340 COMPLETED
Renal Osteodystrophy; End Stage Renal Disease
National Center for Research Resources (NCRR)
 1995-06 PHASE2
NCT00043576 UNKNOWN
Prostate Cancer
Novacea
 2002-08 PHASE2; PHASE3
NCT00066885 COMPLETED
Carcinoma, Non-Small-Cell Lung
Novacea
 2003-06 PHASE1; PHASE2
NCT00057031 UNKNOWN
Myelodysplastic Syndrome
Novacea
 2002-11 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-06-10)

Check the Calcitriol (1,25-Dihydroxyvitamin D3) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Calcitriol functions as a potent agonist that binds the vitamin D receptor, driving receptor heterodimerization and activation of downstream transcriptional programs regulating calcium signaling and cell differentiation. This target engagement promotes intestinal calcium absorption and modulates cellular proliferation, supporting its clinical application in conditions such as secondary hyperparathyroidism, osteoporosis, and prostate cancer.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.