Numerous clinical trials evaluate the therapeutic and nutritional utility of vitamin A acetate and related retinoids across diverse patient populations. Spanning Phase 1 to Phase 4 as well as non-interventional protocols—with recruitment statuses including completed, active, recruiting, terminated, and not yet recruiting—these studies address micronutrient deficiencies, child malnutrition, infant mortality, and lactation supplementation, alongside secondary applications in colorectal adenomas, minimal hepatic encephalopathy, gastrectomy recovery, and morbid obesity. These research efforts are broadly sponsored by academic centers, international health alliances, and philanthropic organizations.
| 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 |
| NCT06058442 | Recruiting | Gastrectomy |
University of Leipzig |
2024-01-24 | Phase 3 |
| NCT06057597 | Recruiting | Obesity|Morbid |
Assistance Publique - Hôpitaux de Paris |
2023-11-13 | Not Applicable |
| NCT06081114 | Recruiting | Micronutrient Status |
Johns Hopkins Bloomberg School of Public Health|International Center for Diarrheal Disease Research Bangladesh (icddrb)|Bill and Melinda Gates Foundation |
2023-10-22 | Not Applicable |
| NCT06155448 | Active not recruiting | Malaria |
Malaria Consortium|Nigerian Institute of Medical Research|London School of Hygiene and Tropical Medicine|Northwestern University |
2023-08-08 | Not Applicable |
| 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 |
| NCT03248700 | COMPLETED | Vitamin A Kinetics |
University of Wisconsin, Madison |
2008-03 | |
| 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>).