Numerous clinical trials evaluate Vitamin A (Retinol) across a diverse spectrum of conditions, including pediatric malnutrition, vitamin A deficiency, infant mortality, dry eye syndrome, colorectal adenomas, and infectious diseases such as malaria. Spanning Early Phase 1 through Phase 4 interventions as well as non-applicable nutritional evaluations, these studies encompass completed, active, terminated, and pending recruitment statuses. The trials are sponsored by diverse entities, including university medical centers, international health research organizations, and governmental institutions.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07335991 | RECRUITING | Vitamin A Deficiency; Idiopathic Scoliosis |
Second Affiliated Hospital of Wenzhou Medical University |
2025-05-13 | |
| NCT07736768 | NOT_YET_RECRUITING | Premature; Preterm Infant Health; Vitamin A Deficiency; Human Milk; Breastfeeding |
University of Mississippi Medical Center |
2026-08-01 | |
| NCT07407101 | COMPLETED | Dry Eye Syndrome (DES) |
University Hospital, Limoges |
2026-04-13 | |
| NCT06438562 | COMPLETED | Healthy Volunteers; Vitamin A |
University of Wisconsin, Madison |
2024-07-10 | |
| NCT03859687 | TERMINATED | Healthy Participants |
St. Jude Children's Research Hospital |
2019-08-19 | PHASE1 |
| NCT06319079 | Not yet recruiting | Lactating Mothers|Infants |
Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri |
2024-03 | Not Applicable |
| NCT06038656 | Recruiting | Resistance Exercise |
North-West University South Africa|Swiss Federal Institute of Technology|King''s College London |
2024-03-01 | Not Applicable |
| NCT06058442 | Recruiting | Gastrectomy |
University of Leipzig |
2024-01-24 | Phase 3 |
| NCT03478865 | COMPLETED | AMD |
National Eye Institute (NEI) |
2018-04-20 | EARLY_PHASE1 |
| NCT05897606 | COMPLETED | Non-Alcoholic Fatty Liver Disease |
Sulaimani Polytechnic University |
2023-02-01 | PHASE1 |
| NCT03870529 | TERMINATED | Non Small Cell Lung Cancer; Stage I Lung Cancer; Stage Ib Lung Carcinoma; Stage IA Lung Carcinoma AJCC V7; Stage IIA Lung Carcinoma; Stage IIIA Lung Carcinoma |
Wake Forest University Health Sciences |
2019-08-19 | EARLY_PHASE1 |
| NCT04920760 | UNKNOWN | Covid19 |
Shiraz University of Medical Sciences |
2021-06-21 | PHASE2 |
| NCT03090048 | UNKNOWN | Acne Vulgaris |
Manchanda Medical Clinic |
2021-04-01 | EARLY_PHASE1 |
| NCT04238845 | UNKNOWN | Malaria; Malnutrition, Child |
Institut de Recherche en Sciences de la Sante, Burkina Faso |
2020-07-13 | |
| NCT04156321 | UNKNOWN | Assess the Impact of Moringa Leaves on Serum Heamoglobin and Vitamin A Level Among the Adolescent Girls |
International Centre for Diarrhoeal Disease Research, Bangladesh |
2019-09-01 | PHASE3 |
| NCT03640104 | COMPLETED | Overweight and Obesity; Vitamin A Deficiency; Dietary Modification; Breastfeeding |
Universidad de Sonora |
2018-11-01 | |
| NCT03482063 | COMPLETED | Neurocognitive Function; Mood |
Swisse Wellness Pty Ltd |
2018-06-18 | PHASE2 |
| NCT03000543 | COMPLETED | Healthy Infants; Infants With an Inflammatory Condition |
International Centre for Diarrhoeal Disease Research, Bangladesh |
2016-11-01 | |
| NCT03332602 | COMPLETED | Iron-deficiency |
Swiss Federal Institute of Technology |
2018-04-04 | |
| NCT02699099 | COMPLETED | Malaria; Malaria Vaccines |
GlaxoSmithKline |
2017-05-10 | PHASE3 |
| NCT02043223 | COMPLETED | Vitamin A Deficiency |
International Centre for Diarrhoeal Disease Research, Bangladesh |
2013-10 | PHASE2; PHASE3 |
| NCT02557373 | COMPLETED | Dietary Rice Bran Supplementation |
Colorado State University |
2015-08 | |
| NCT02227459 | COMPLETED | Moderate to Extensive Hepatic Fibrosis (METAVIR F3-4) |
Bristol-Myers Squibb |
2014-10 | PHASE1 |
| NCT01929694 | COMPLETED | Affect and Exertion During and Post-exercise |
Northumbria University |
2013-09 | PHASE4 |
| NCT01583972 | COMPLETED | Vitamin A Deficiency |
USDA, Western Human Nutrition Research Center |
2012-01 | |
| NCT01199445 | COMPLETED | Vitamin A Deficiency |
Swiss Federal Institute of Technology |
2010-08 | EARLY_PHASE1 |
| NCT00211341 | COMPLETED | Vitamin A Deficiency; Maternal Mortality; Maternal Morbidity |
London School of Hygiene and Tropical Medicine |
2000-12 | PHASE3 |
| NCT00431691 | COMPLETED | Retina; Regional Blood Flow; Endotoxin, Escherichia Coli |
Medical University of Vienna |
2006-09 | PHASE4 |
| NCT00053612 | COMPLETED | HIV Infections; Vitamin A Deficiency; HIV Seronegativity |
National Institute of Allergy and Infectious Diseases (NIAID) |
PHASE2 | |
| NCT03152474 | COMPLETED | Sepsis |
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center |
1993-02 | PHASE4 |
| NCT02319499 | COMPLETED | Development; Iron Deficiency; Zinc Deficiency |
Indonesia University |
1998-08 | PHASE3 |
| NCT01437826 | TERMINATED | Colorectal Adenomas |
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy |
1988-03 | PHASE3 |
| NCT00168610 | UNKNOWN | Infant Mortality; Morbidity |
Bandim Health Project |
2004-11 | PHASE4 |
| NCT00222547 | COMPLETED | Village Children |
University of Oxford |
1999-01 | PHASE4 |
| NCT00063596 | UNKNOWN | Infant, Premature |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
2000-01 | |
| NCT00000114 | COMPLETED | Retinitis Pigmentosa |
National Eye Institute (NEI) |
1984-05 | PHASE3 |
| NCT00170404 | COMPLETED | Mycobacterium Tuberculosis |
National Institute of Allergy and Infectious Diseases (NIAID) |
2000-06 | PHASE3 |
| NCT00057434 | COMPLETED | Pulmonary Tuberculosis; HIV Infections |
National Institute of Allergy and Infectious Diseases (NIAID) |
1998-09 | PHASE3 |
(data from https://clinicaltrials.gov, updated on 2026-05-15)
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>).