Clinical Trials

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)

Check the Vitamin A Acetate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Vitamin A acetate undergoes enzymatic cleavage to active retinol, which binds nuclear retinoic acid receptors and retinoid X receptors to modulate gene expression pathways governing cellular differentiation and immune homeostasis. This transcriptional regulation promotes epithelial tissue integrity and immune cell function, providing a mechanistic rationale for its clinical evaluation in correcting vitamin A deficiency, lowering infant mortality, and improving pediatric micronutrient status.

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.