Numerous clinical trials evaluate calcifediol across Phase 1 through Phase 4 and non-interventional studies for metabolic, renal, and infectious conditions, including vitamin D deficiency, secondary hyperparathyroidism stemming from chronic kidney disease, osteopenia, and COVID-19 pneumonia. Sponsored by academic medical centers, university hospitals, and pharmaceutical organizations, these studies encompass recruiting, completed, and terminated statuses, highlighting active clinical translation into dosing strategies and therapeutic protocols.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06258850 | NOT_YET_RECRUITING | Pulmonary Artery Hypertension; Vitamin d Deficiency |
Parc de Salut Mar |
2024-07-01 | PHASE4 |
| NCT06279910 | Recruiting | SARS-CoV 2 Pneumonia |
Complejo Hospitalario Universitario de Albacete |
2024-02-21 | -- |
| NCT05732883 | Not yet recruiting | Voice Change|Hypocalcemia |
Tseung Kwan O Hospital Hong Kong|United Christian Hospital|Chinese University of Hong Kong |
2024-01-01 | Phase 2 |
| NCT02548364 | COMPLETED | Myocardial Infarction |
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz |
2015-10 | PHASE3 |
| NCT05540678 | Recruiting | Nutritional and Metabolic Diseases|Child Obesity|Adolescent Obesity |
Insel Gruppe AG University Hospital Bern|DCB Research AG |
2022-11-30 | Not Applicable |
| NCT04735926 | COMPLETED | Vitamin D Deficiency; Vitamin D Insufficiency |
Faes Farma, S.A. |
2020-12-23 | PHASE2; PHASE3 |
| NCT04366908 | COMPLETED | SARS-CoV 2; COVID19; SARS (Severe Acute Respiratory Syndrome); Cytokine Release Syndrome; Cytokine Storm |
Maimónides Biomedical Research Institute of Córdoba |
2020-05-07 | PHASE2 |
| NCT05819918 | Completed | COVID-19 |
Maimónides Biomedical Research Institute of Córdoba |
2022-04-01 | -- |
| NCT04551911 | COMPLETED | COVID-19; Coronavirus; SARS-CoV2 Infection |
OPKO Health, Inc. |
2020-11-02 | PHASE2 |
| NCT03602261 | TERMINATED | Secondary Hyperparathyroidism Due to Renal Causes; Chronic Kidney Diseases; Vitamin D Deficiency; Stage 5 Chronic Kidney Disease |
OPKO Health, Inc. |
2018-07-09 | PHASE2 |
| NCT02962102 | COMPLETED | Critically Ill; Acute Kidney Injury |
David Leaf |
2017-04-03 | PHASE2 |
| NCT03588884 | COMPLETED | Secondary Hyperparathyroidism Due to Renal Causes; Vitamin D Insufficiency; CKD Stage 3; CKD Stage 4 |
OPKO Health, Inc. |
2018-06-08 | PHASE4 |
| NCT04386850 | Unknown status | COVID 19 |
Tehran University of Medical Sciences|Boston University |
2020-04-14 | Phase 2|Phase 3 |
| NCT03213886 | COMPLETED | Hip Fracture; Vitamin D Deficiency |
Leonor Cuadra Llopart |
2018-01-01 | PHASE4 |
| NCT03401541 | COMPLETED | Vitamin D Deficiency; Fat Malabsorption |
Boston University |
2018-10-01 | EARLY_PHASE1 |
| NCT03660800 | COMPLETED | Vitamin D Insufficiency; Secondary Hyperparathyroidism |
OPKO Health, Inc. |
2018-08-20 | PHASE1 |
| NCT02527668 | COMPLETED | Osteopenia/Osteoporosis |
dsm-firmenich Switzerland AG |
2015-09 | PHASE2 |
| NCT03403933 | COMPLETED | Hypovitaminosis D; Cardiovascular Diseases |
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio |
2017-01-16 | PHASE4 |
| NCT02805907 | COMPLETED | Asthma, Bronchial |
MurciaSalud |
2016-06 | PHASE4 |
| NCT02349282 | COMPLETED | Deficiency, Vitamin D; Elderly, Frail |
Wageningen University |
2014-12 | |
| NCT02333682 | COMPLETED | Osteoporosis |
dsm-firmenich Switzerland AG |
2014-11 | |
| NCT01939977 | COMPLETED | Secondary Hyperparathyroidism Due to Renal Causes |
Fundación Senefro |
2014-01 | PHASE4 |
| NCT01868945 | COMPLETED | Pre-frail Elderly; Frail Elderly |
dsm-firmenich Switzerland AG |
2013-04 | PHASE1 |
(data from https://clinicaltrials.gov, updated on 2024-02-14)
Check the
Calcifediol
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
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>).
Note: Technical data last updated: Sep 1, 2026.