Clinical Trials

Numerous clinical trials spanning Early Phase 1 through Phase 4 evaluate retinyl palmitate across healthy volunteers and conditions such as vitamin A deficiency, dyslipidemia, cardiovascular diseases, chronic liver disease, environmental enteric dysfunction, and facial acne vulgaris. Supported by academic, governmental, and university sponsors—including Johns Hopkins Bloomberg School of Public Health, Columbia University, and the USDA—these protocols encompass completed, recruiting, terminated, and not yet recruiting statuses.

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
NCT05702398 RECRUITING
Skin Cancer; Kidney Transplant Recipients
Rhode Island Hospital
 2023-04-01 EARLY_PHASE1
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
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
NCT04137354 COMPLETED
Anemia, Iron Deficiency; Vitamin A Deficiency; Cognitive Development; Helminthic Infection
University Ghent
 2020-11-02
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
NCT04080869 COMPLETED
Facial Acne Vulgaris
Assiut University
 2020-01-06 PHASE2
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
NCT02804490 COMPLETED
Vitamin A Deficiency
Johns Hopkins Bloomberg School of Public Health
 2016-03 PHASE3
NCT03632876 COMPLETED
Sickle Cell Anemia in Children; Vitamin A Deficiency in Children
Children's Hospital of Philadelphia
 2015-10-02
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
NCT02210507 COMPLETED
Vitamin A Deficiency
USDA, Western Human Nutrition Research Center
 2014-07
NCT01929694 COMPLETED
Affect and Exertion During and Post-exercise
Northumbria University
 2013-09 PHASE4
NCT01225289 COMPLETED
Relapsing Remitting Multiple Sclerosis
Tehran University of Medical Sciences
 2009-10 PHASE4
NCT01922713 COMPLETED
Vitamin A Deficiency
University of California, Davis
 2013-10
NCT01583972 COMPLETED
Vitamin A Deficiency
USDA, Western Human Nutrition Research Center
 2012-01
NCT01476358 UNKNOWN
Vitamin A Deficiency
London School of Hygiene and Tropical Medicine
 2011-11 PHASE2
NCT01803659 COMPLETED
Vitamin A Status
University of California, Davis
 2013-01
NCT01705457 UNKNOWN
Relapsing Remitting Multiple Sclerosis
Tehran University of Medical Sciences
 2010-02 PHASE4
NCT01814891 COMPLETED
Vitamin A Status With Maize Feeding
University of Wisconsin, Madison
 2012-05
NCT01958775 Completed
Dyslipidemia
University Health Network Toronto
 2012-03 Phase 3
NCT01493297 COMPLETED
Iron Absorption
Swiss Federal Institute of Technology
 2011-09
NCT01381276 COMPLETED
Vitamin A Deficiency
USDA, Western Human Nutrition Research Center
 2011-06 PHASE2
NCT01420406 COMPLETED
Vitamin A Deficiency
USDA, Western Human Nutrition Research Center
 2010-06
NCT01199445 COMPLETED
Vitamin A Deficiency
Swiss Federal Institute of Technology
 2010-08 EARLY_PHASE1
NCT00453648 COMPLETED
Vitamin A Deficiency
University of California, Davis
 2006-03
NCT04123210 COMPLETED
Vitamin A Deficiency
University of Wisconsin, Madison
 2008-03-17
NCT02867488 Completed
Biological Availability
Iowa State University
 2009-04 Not Applicable
NCT00211341 COMPLETED
Vitamin A Deficiency; Maternal Mortality; Maternal Morbidity
London School of Hygiene and Tropical Medicine
 2000-12 PHASE3
NCT01634698 COMPLETED
Chronic Liver Disease
Universidade Federal do Rio de Janeiro
 2007-10
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
NCT00000116 COMPLETED
Retinitis Pigmentosa
Carol Weigel DiFranco
 1996-05 PHASE3
NCT00198718 COMPLETED
Vitamin A Deficiency; HIV
Johns Hopkins Bloomberg School of Public Health
 1997-11 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 Retinyl (Vitamin A) Palmitate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Upon enzymatic cleavage to active retinol and subsequent conversion to retinoic acid, retinyl palmitate binds to nuclear retinoic acid receptors and retinoid X receptors, altering gene transcription to regulate cellular growth, epithelial differentiation, and lipid metabolism. This receptor-mediated signaling promotes tissue restoration and systemic nutrient balance, providing the mechanistic basis for its clinical application in addressing vitamin A deficiency, facial acne vulgaris, and metabolic dyslipidemia in cardiovascular disease.

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>).

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Note: Technical data last updated: Sep 1, 2026.