Active Ingredient History
Cholecalciferol (/ˌkoʊləkælˈsɪfərɒl/) (vitamin D3) is one of the five forms of vitamin D. Cholecalciferol is a steroid hormone that has long been known for its important role in regulating body levels of calcium and phosphorus, in mineralization of bone, and for the assimilation of Vitamin A. The classical manifestation of vitamin D deficiency is rickets, which is seen in children and results in bony deformities including bowed long bones. Most people meet at least some of their vitamin D needs through exposure to sunlight. Ultraviolet (UV) B radiation with a wavelength of 290–320 nanometers penetrates uncovered skin and converts cutaneous 7-dehydrocholesterol to previtamin D3, which in turn becomes vitamin D3. In supplements and fortified foods, vitamin D is available in two forms, D2 (ergocalciferol) and D3 (cholecalciferol) that differ chemically only in their side-chain structure. Vitamin D2 is manufactured by the UV irradiation of ergosterol in yeast, and vitamin D3 is manufactured by the irradiation of 7-dehydrocholesterol from lanolin and the chemical conversion of cholesterol. The two forms have traditionally been regarded as equivalent based on their ability to cure rickets and, indeed, most steps involved in the metabolism and actions of vitamin D2 and vitamin D3 are identical. Both forms (as well as vitamin D in foods and from cutaneous synthesis) effectively raise serum 25(OH) D levels. Firm conclusions about any different effects of these two forms of vitamin D cannot be drawn. However, it appears that at nutritional doses, vitamins D2 and D3 are equivalent, but at high doses, vitamin D2 is less potent. The American Academy of Pediatrics (AAP) recommends that exclusively and partially breastfed infants receive supplements of 400 IU/day of vitamin D shortly after birth and continue to receive these supplements until they are weaned and consume ≥1,000 mL/day of vitamin D-fortified formula or whole milk. Cholecalciferol is used in diet supplementary to treat Vitamin D Deficiency. Cholecalciferol is inactive: it is converted to its active form by two hydroxylations: the first in the liver, the second in the kidney, to form calcitriol, whose action is mediated by the vitamin D receptor, a nuclear receptor which regulates the synthesis of hundreds of enzymes and is present in virtually every cell in the body. Calcitriol increases the serum calcium concentrations by increasing GI absorption of phosphorus and calcium, increasing osteoclastic resorption, and increasing distal renal tubular reabsorption of calcium. Calcitriol appears to promote intestinal absorption of calcium through binding to the vitamin D receptor in the mucosal cytoplasm of the intestine. Subsequently, calcium is absorbed through formation of a calcium-binding protein. NCATS
Combination drugs
| Organization | Org Type | FDA approvals | Clinical Trials involvement | Org ID | Force Sort |
|---|
| Organization | Org Type | FDA approvals | Clinical Trials involvement | Org ID | Force Sort |
|---|
Abortion, Habitual (Phase 2/Phase 3)
Accidental Falls (Phase 3)
Accidents (Phase 4)
Acne Vulgaris (Phase 4)
Acquired Immunodeficiency Syndrome (Phase 2)
Acromegaly (Phase 1)
Acute Chest Syndrome (Phase 2)
Acute Coronary Syndrome (Phase 4)
ADAMTS13 Protein (Phase 1/Phase 2)
Adenocarcinoma (Early Phase 1)
Adenoma (Phase 2/Phase 3)
Adenomatous Polyps (Phase 3)
Adrenoleukodystrophy (Phase 1/Phase 2)
Aging (Phase 3)
Allergy and Immunology (Phase 1/Phase 2)
Alopecia Areata (Phase 1/Phase 2)
Alveolar Bone Loss (Phase 2)
Alzheimer Disease (Phase 3)
Amenorrhea (Phase 4)
Anemia (Phase 4)
Anemia, Aplastic (Phase 4)
Anemia, Hemolytic, Congenital (Phase 2)
Anemia, Iron-Deficiency (Phase 3)
Anemia, Sickle Cell (Phase 4)
Aortic Valve Disease (Phase 2)
Aortic Valve Stenosis (Phase 1)
Apoptosis (Phase 4)
Arterial Occlusive Diseases (Phase 2/Phase 3)
Arthralgia (Phase 2)
Arthritis, Juvenile (Phase 3)
Arthritis, Rheumatoid (Phase 4)
Arthrodesis (Early Phase 1)
Ascorbic Acid Deficiency (Phase 2)
Aspergillosis, Allergic Bronchopulmonary (Phase 2/Phase 3)
Asthma (Phase 4)
Atherosclerosis (Phase 2)
Autistic Disorder (Phase 2/Phase 3)
Autoimmune Diseases (Phase 3)
Avitaminosis (Phase 4)
Bariatric Surgery (Phase 4)
Barrett Esophagus (Early Phase 1)
Benign Paroxysmal Positional Vertigo (Phase 4)
beta-Thalassemia (Phase 4)
Bleeding Time (Phase 2)
Blood (Phase 4)
Bone Density (Phase 2)
Bone Diseases (Phase 4)
Bone Diseases, Metabolic (Phase 4)
Bone Neoplasms (Phase 1)
Brain Death (Phase 3)
Brain Neoplasms (Phase 2/Phase 3)
Breast Density (Phase 1)
Breast Diseases (Phase 2)
Breast Neoplasms (Phase 3)
Bronchiectasis (Phase 4)
Bronchiolitis (Phase 4)
Bronchiolitis Obliterans (Phase 4)
Bronchitis (Phase 3)
Bronchopulmonary Dysplasia (Phase 2/Phase 3)
Burns (Phase 4)
Calcium (Phase 4)
Calcium Metabolism Disorders (Phase 4)
Carcinoma, Hepatocellular (Phase 4)
Carcinoma, Intraductal, Noninfiltrating (Phase 1/Phase 2)
Carcinoma, Non-Small-Cell Lung (Phase 4)
Carcinoma, Transitional Cell (Phase 4)
Cardiomyopathies (Phase 4)
Cardio-Renal Syndrome (Phase 4)
Cardiovascular Diseases (Phase 4)
Cholecalciferol (Phase 4)
Chronic Pain (Phase 4)
Cluster Headache (Phase 3)
Cognition Disorders (Phase 3)
Cognitive Dysfunction (Phase 2/Phase 3)
Colic (Phase 2)
Colitis, Ulcerative (Phase 3)
Colles' Fracture (Phase 4)
Colonic Neoplasms (Phase 3)
Colorectal Neoplasms (Phase 3)
Common Cold (Phase 2)
Communicable Diseases (Phase 3)
Conjunctivitis (Phase 2)
Coronary Artery Disease (Phase 3)
Coronary Disease (Phase 3)
Coronavirus (Phase 3)
Coronavirus Infections (Phase 2)
COVID-19 (Phase 4)
Craniocerebral Trauma (Phase 2/Phase 3)
Critical Illness (Phase 4)
Crohn Disease (Phase 4)
Cystic Fibrosis (Phase 4)
Cytokines (Phase 4)
Death (Phase 4)
Deficiency Diseases (Phase 2)
Depression (Phase 4)
Dermatitis, Atopic (Phase 4)
Dermatology (Early Phase 1)
Diabetes, Gestational (Phase 4)
Diabetes Mellitus (Phase 4)
Diabetes Mellitus, Type 1 (Phase 4)
Diabetes Mellitus, Type 2 (Phase 4)
Diabetic Nephropathies (Phase 4)
Diabetic Neuropathies (Phase 4)
Dialysis (Phase 4)
Dietary Supplements (Phase 4)
Disseminated Intravascular Coagulation (Phase 2)
Drug Resistant Epilepsy (Phase 3)
Drugs, Investigational (Phase 1)
Dry Eye Syndromes (Phase 4)
Dysbiosis (Phase 4)
Dyslipidemias (Phase 3)
Dysmenorrhea (Phase 3)
Eclampsia (Phase 4)
Endocrine System Diseases (Phase 3)
Endometrial Neoplasms (Phase 2)
Endometriosis (Phase 4)
Endothelial Cells (Phase 1)
Enteral Nutrition (Phase 4)
Enterocolitis, Necrotizing (Phase 4)
Epidermolysis Bullosa (Phase 4)
Epilepsy (Phase 4)
Esophageal Neoplasms (Phase 3)
Executive Function (Phase 2)
Familial Hypophosphatemic Rickets (Phase 3)
Fatigue (Phase 4)
Femoral Neck Fractures (Phase 3)
Fibromyalgia (Phase 4)
Fibrosis (Phase 2)
Flaviviridae Infections (Phase 4)
Flushing (Phase 1)
Food Hypersensitivity (Phase 4)
Fractures, Bone (Phase 4)
Frail Elderly (Phase 3)
Frailty (Phase 4)
Gastrectomy (Phase 2)
Gastric Bypass (Phase 3)
Gastrointestinal Neoplasms (Phase 1)
Gaucher Disease (Phase 4)
Geriatrics (Phase 3)
Giant Cell Arteritis (Phase 3)
Giant Cell Tumor of Bone (Phase 2)
Giant Cell Tumors (Phase 2)
Glioblastoma (Phase 1/Phase 2)
Glucose Intolerance (Phase 4)
Glucose Metabolism Disorders (Phase 3)
Graft Rejection (Phase 4)
Granulomatosis with Polyangiitis (Phase 3)
Granulomatous Disease, Chronic (Phase 2/Phase 3)
Growth (Phase 1)
Hamartoma (Phase 2)
Healthy Volunteers (Phase 4)
Heart Defects, Congenital (Phase 2)
Heart Diseases (Phase 3)
Heart Failure (Phase 4)
Helicobacter pylori (Phase 3)
HELLP Syndrome (Phase 4)
Hematologic Neoplasms (Phase 2)
Hematopoietic Stem Cell Transplantation (Phase 4)
Hemodialysis, Home (Phase 4)
Hemorrhage (Phase 2)
Hepatitis B (Phase 4)
Hepatitis C (Phase 4)
Hepatitis C, Chronic (Phase 4)
Hip Fractures (Phase 4)
HIV (Phase 3)
HIV Infections (Phase 3)
Hyaline Membrane Disease (Phase 4)
Hypercalcemia (Phase 4)
Hypercalciuria (Phase 4)
Hyperglycemia (Phase 3)
Hyperhomocysteinemia (Phase 2)
Hyperlipidemias (Phase 3)
Hyperparathyroidism (Phase 4)
Hyperparathyroidism, Primary (Phase 4)
Hyperparathyroidism, Secondary (Phase 4)
Hypersensitivity (Phase 4)
Hypertension (Phase 4)
Hypertension, Pregnancy-Induced (Phase 4)
Hypocalcemia (Phase 4)
Hypoglycemia (Phase 1/Phase 2)
Hypogonadism (Phase 4)
Hypoparathyroidism (Phase 4)
Immune System Diseases (Phase 3)
Immune Tolerance (Phase 4)
Infant, Newborn, Diseases (Phase 3)
Infant Nutrition Disorders (Phase 2/Phase 3)
Infant, Premature (Phase 4)
Infant, Premature, Diseases (Phase 3)
Infections (Phase 3)
Infertility (Phase 4)
Infertility, Female (Phase 4)
Infertility, Male (Phase 2/Phase 3)
Inflammation (Phase 4)
Inflammatory Bowel Diseases (Phase 3)
Influenza, Human (Phase 3)
Insulin Resistance (Phase 4)
Intensive Care Units (Phase 3)
Interleukin-6 (Phase 1/Phase 2)
Intracranial Aneurysm (Phase 2/Phase 3)
Intracranial Hemorrhages (Phase 2/Phase 3)
Intraocular Pressure (Phase 2)
Iron Deficiencies (Phase 3)
Irritable Bowel Syndrome (Phase 1)
Irritants (Phase 1)
Keratosis, Actinic (Phase 2)
Kidney Diseases (Phase 4)
Kidney Failure, Chronic (Phase 4)
Kidney Neoplasms (Phase 4)
Kidney Transplantation (Phase 4)
Latent Tuberculosis (Phase 3)
Leukemia (Phase 3)
Leukemia, Lymphocytic, Chronic, B-Cell (Phase 3)
Leukemia, Lymphoid (Phase 4)
Leukemia, Monocytic, Acute (Phase 2)
Leukemia, Myeloid, Acute (Phase 4)
Leukemia, Myelomonocytic, Acute (Phase 2)
Lipid Metabolism Disorders (Phase 2)
Liver Neoplasms (Early Phase 1)
Lung Diseases (Phase 2)
Lung Neoplasms (Phase 3)
Lung Transplantation (Phase 4)
Lupus Erythematosus, Cutaneous (Phase 2)
Lupus Erythematosus, Systemic (Phase 2)
Lymphoma (Phase 4)
Lymphoma, B-Cell, Marginal Zone (Phase 3)
Lymphoma, Follicular (Phase 3)
Lymphoma, Large B-Cell, Diffuse (Phase 3)
Lymphoma, Non-Hodgkin (Phase 3)
Magnesium Deficiency (Phase 4)
Malnutrition (Phase 4)
Melanoma (Phase 3)
Memory Disorders (Phase 3)
Meningitis (Phase 2/Phase 3)
Menopause, Premature (Phase 1)
Mental Health (Phase 4)
Metabolic Diseases (Phase 3)
Metabolic Syndrome (Phase 4)
Metabolism (Phase 2)
Migraine Disorders (Phase 3)
Mucositis (Phase 2)
Multidetector Computed Tomography (Phase 1)
Multiple Myeloma (Phase 3)
Multiple Organ Failure (Phase 3)
Multiple Sclerosis (Phase 4)
Multiple Sclerosis, Relapsing-Remitting (Phase 4)
Muscles (Phase 4)
Muscle Strength (Phase 1)
Muscle Weakness (Phase 4)
Musculoskeletal Diseases (Phase 2/Phase 3)
Myalgia (Phase 2)
Mycobacterium bovis (Phase 2/Phase 3)
Myelodysplastic Syndromes (Phase 4)
Myeloproliferative Disorders (Phase 2)
Myocardial Infarction (Phase 4)
Myocardial Ischemia (Phase 3)
Nasal Obstruction (Early Phase 1)
Neoplasm Metastasis (Phase 4)
Neoplasms (Phase 4)
Nephrolithiasis (Phase 2/Phase 3)
Nephrotic Syndrome (Phase 4)
Nerve Fibers (Phase 3)
Neurofibroma (Phase 2)
Non-alcoholic Fatty Liver Disease (Phase 3)
Nutritional Status (Phase 1)
Nutrition Disorders (Phase 2)
Obesity (Phase 4)
Obesity, Abdominal (Phase 2)
Obesity, Morbid (Phase 4)
Only Child (Phase 3)
Opioid-Related Disorders (Phase 4)
Optic Neuritis (Phase 2)
Organs at Risk (Phase 3)
Osteitis Deformans (Phase 3)
Osteoarthritis (Phase 2)
Osteoarthritis, Knee (Phase 4)
Osteogenesis Imperfecta (Phase 4)
Osteoporosis (Phase 4)
Osteoporosis, Postmenopausal (Phase 4)
Osteoporotic Fractures (Phase 4)
Ovarian Neoplasms (Phase 2)
Overweight (Phase 4)
Ovulation Induction (Phase 3)
Oxidative Stress (Phase 2)
Paget Disease, Extramammary (Phase 4)
Pain (Phase 3)
Pain, Postoperative (Phase 4)
Pancreatic Neoplasms (Phase 3)
Pancreatitis, Chronic (Phase 4)
Parathyroid Hormone (Phase 3)
Parkinson Disease (Phase 4)
Patient Compliance (Phase 4)
Pediatric Obesity (Phase 4)
Pediatrics (Phase 2)
Periodontal Diseases (Early Phase 1)
Periodontitis (Phase 1)
Peripheral Arterial Disease (Phase 4)
Peritoneal Dialysis (Phase 2)
Physical Fitness (Phase 4)
Pituitary ACTH Hypersecretion (Phase 1)
Pneumonia (Phase 4)
Polycystic Ovary Syndrome (Phase 4)
Polymyalgia Rheumatica (Phase 3)
Polymyositis (Phase 3)
Polyps (Phase 2/Phase 3)
Postmenopause (Phase 4)
Prediabetic State (Phase 4)
Pre-Eclampsia (Phase 4)
Pregnancy (Phase 3)
Pregnancy Complications (Phase 3)
Premature Birth (Phase 4)
Primary Immunodeficiency Diseases (Phase 1/Phase 2)
Prostatic Neoplasms (Phase 3)
Proteinuria (Phase 3)
Psoriasis (Phase 4)
Psychological Distress (Phase 2)
Psychotic Disorders (Phase 2)
Pulmonary Disease, Chronic Obstructive (Phase 4)
Quality of Life (Phase 4)
Renal Dialysis (Phase 3)
Renal Insufficiency (Phase 4)
Renal Insufficiency, Chronic (Phase 4)
Respiration Disorders (Phase 2)
Respiratory Distress Syndrome (Phase 3)
Respiratory Insufficiency (Phase 2)
Respiratory Sounds (Phase 4)
Respiratory Tract Diseases (Phase 2)
Respiratory Tract Infections (Phase 4)
Restless Legs Syndrome (Phase 4)
Rhinitis (Phase 3)
Rhinitis, Allergic (Phase 3)
Rhinitis, Allergic, Seasonal (Phase 4)
Rhinovirus (Phase 3)
Rickets (Phase 2/Phase 3)
RNA Virus Infections (Phase 4)
Sarcopenia (Phase 4)
Schizophrenia (Phase 3)
Scoliosis (Phase 3)
Seasonal Affective Disorder (Phase 4)
Seizures (Phase 2/Phase 3)
Sepsis (Phase 3)
Severe Acute Malnutrition (Phase 2)
Severe Acute Respiratory Syndrome (Phase 2)
Sinusitis (Phase 3)
Skin Neoplasms (Phase 1)
Skin Pigmentation (Phase 1/Phase 2)
Spinal Cord Injuries (Phase 3)
Stomach Neoplasms (Phase 3)
Stroke (Phase 2/Phase 3)
Sunlight (Phase 3)
Thoracic Surgery (Phase 2)
Thyroid Diseases (Early Phase 1)
Thyroiditis, Autoimmune (Phase 2)
Tibial Fractures (Phase 1)
Toxemia (Phase 4)
Triple Negative Breast Neoplasms (Phase 2)
Tuberculosis (Phase 3)
Tuberculosis, Pulmonary (Phase 4)
Ureteral Neoplasms (Phase 2)
Urinary Bladder Neoplasms (Phase 2)
Urinary Tract Infections (Phase 2)
Urticaria (Phase 4)
Uterine Cervical Neoplasms (Phase 2)
Uterine Neoplasms (Phase 2)
Vascular Calcification (Phase 4)
Vascular Stiffness (Phase 4)
Vitamin D (Phase 4)
Vitamin D Deficiency (Phase 4)
Vitamin K 2 (Phase 1)
Warts (Phase 2)
| Trial | Phase | Start Date | Organizations | Indications |
|---|
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