Clinical Trials

Numerous clinical trials investigate the therapeutic and nutritional applications of (±)-α-tocopherol across conditions including type 2 diabetes mellitus, cardiovascular diseases, morbid obesity, micronutrient deficiencies, ischemia-reperfusion injury, and breast neoplasms. Ranging from Phase 1 through Phase 4 alongside non-interventional designs, these studies are sponsored by academic medical centers, government institutes, and global health foundations. Currently, recruitment statuses span from not yet recruiting and actively recruiting to completed or terminated.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06634056 RECRUITING
Non-Small Cell Lung Cancer; Radiation Induced Lung Injury (RILI)
University Health Network, Toronto
 2026-06-15 PHASE2
NCT06912763 RECRUITING
Fibrosis Syndrome; Lymphedema; Head &Amp; Neck Cancer; Fibrosis
M.D. Anderson Cancer Center
 2025-08-08 PHASE2
NCT06494111 RECRUITING
Lymphedema; Fibrosis
M.D. Anderson Cancer Center
 2025-02-13 PHASE2
NCT07796204 NOT_YET_RECRUITING
Obesity; Type 2 Diabetes
Pennington Biomedical Research Center
 2026-09-03
NCT05795647 RECRUITING
Medication-related Osteonecrosis of the Jaw (MRONJ)
University Hospital, Limoges
 2024-02-29 PHASE2
NCT07782411 NOT_YET_RECRUITING
Obesity (BMI>30); Neuroinflammation
Autonomous University of Morelos
 2026-08-10
NCT06915701 RECRUITING
Rheumatoid Arthritis
University of Guadalajara
 2026-02-06 PHASE2; PHASE3
NCT03040778 ACTIVE_NOT_RECRUITING
Medication-related Osteonecrosis of the Jaw; Bisphosphonate-related Osteonecrosis of the Jaw; Avascular Necrosis
University of Washington
 2018-04-01 PHASE3
NCT06323538 Not yet recruiting
Dietary Exposure|Diabetes Mellitus Type 2|Cardiovascular Diseases|Bone Loss|Sustainability|Exposure|Obesity|Vitamin Deficiency|Mineral Deficiency
German Federal Institute for Risk Assessment|Max Rubner-Institut|University of Bonn|Research Institute for Plant-Based Nutrition|University of Jena|University of Regensburg|Heidelberg University|University of Vienna
 2024-04-01 --
NCT06319079 Not yet recruiting
Lactating Mothers|Infants
Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri
 2024-03 Not Applicable
NCT05813249 COMPLETED
Non-alcoholic Fatty Liver Disease
Zagazig University
 2023-02-15 PHASE4
NCT07194304 COMPLETED
Tetralogy of Fallot (TOF); Alpha-tocopherol; Cardiac Surgery
Dr Cipto Mangunkusumo General Hospital
 2022-05-01 EARLY_PHASE1
NCT06058442 Recruiting
Gastrectomy
University of Leipzig
 2024-01-24 Phase 3
NCT06409546 COMPLETED
Medically Related Osteonecrosis of the Jaws
University of Catania
 2020-04-02
NCT05350124 UNKNOWN
Restless Legs Syndrome; End Stage Renal Disease
King Abdulaziz University
 2022-11 PHASE3
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
NCT03444298 COMPLETED
Airway Inflammation; Asthma
University of North Carolina, Chapel Hill
 2018-06-08 PHASE2
NCT05711810 COMPLETED
Severe Acute Respiratory Syndrome-related Coronavirus; Renal Dialysis; Vaccines; Myocarditis Allergic; Infection Viral
Yang I. Pachankis
 2023-01-02 PHASE4
NCT07610304 COMPLETED
Dyslipidaemia
NUR International University
 2022-06-15 PHASE2
NCT04360889 COMPLETED
Lower Extremity Lymphedema
Ryazan State Medical University
 2019-09-01 PHASE4
NCT03723291 COMPLETED
Head and Neck Fibrosis
University College, London
 2019-09-01 PHASE1
NCT05016349 UNKNOWN
Breast Cancer Female
Mahmoud Ramadan mohamed Elkazzaz
 2021-08 PHASE3
NCT07412574 COMPLETED
COVID - 19
Universidad Veracruzana
 2020-09-27 EARLY_PHASE1
NCT05028907 COMPLETED
Ophthalmopathy , Lacrimal System
Sohag University
 2020-11-15 PHASE4
NCT02898376 UNKNOWN
Breast Carcinoma; Fibrosis
Institut de Cancérologie de Lorraine
 2018-12 PHASE3
NCT03416777 COMPLETED
Nutrition Aspect of Cancer; Diet Modification; Cancer of Colon
Azienda Ospedaliero-Universitaria Careggi
 2019-06-01
NCT02911688 COMPLETED
Allergic Asthma
University of North Carolina, Chapel Hill
 2016-09 PHASE2
NCT02251041 COMPLETED
Reperfusion Injury
Universitaire Ziekenhuizen KU Leuven
 2014-09 PHASE2
NCT03460860 COMPLETED
Skin Aging; Wrinkles
United Laboratories
 2018-03-05
NCT02793648 COMPLETED
Depression
Yolanda de Diego Otero
 2014-10 PHASE2
NCT03948737 COMPLETED
Beta Thalassemia Major Anemia; Hemolysis; Oxidative Stress
Indonesia University
 2016-12-30
NCT01291433 COMPLETED
Radiation Induced Brachial Plexopathy
Assistance Publique - Hôpitaux de Paris
 2011-03 PHASE3
NCT00862433 COMPLETED
Diabetes; Fatty Liver; Obesity; Healthy Volunteers
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 2014-10-10 PHASE1
NCT02104505 COMPLETED
Mild, Allergic Asthma
University of North Carolina, Chapel Hill
 2015-11 PHASE1; PHASE2
NCT02592109 COMPLETED
Complementary Feeding Recommendation; Linear Programming,; Nutritional Status; Omega-3 Fatty Acids; Malondialdehyde; Alpha-Tocopherol; Overweight
Indonesia University
 2015-11 PHASE2
NCT02368457 COMPLETED
Osteoradionecrosis
Hospital Vall d'Hebron
 2016-02 PHASE4
NCT02610829 COMPLETED
Gamma Tocopherol Serum Levels
University of North Carolina, Chapel Hill
 2015-11
NCT01457690 COMPLETED
Hypobetalipoproteinemias
Hospices Civils de Lyon
 2011-10 PHASE3
NCT01329770 COMPLETED
Fragile X Syndrome
Yolanda de Diego Otero
 2010-12 PHASE2
NCT02473302 COMPLETED
Colorectal Cancer
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
 2014-04
NCT01665742 COMPLETED
Overweight; Obesity
University College Dublin
 2012-01
NCT00466596 COMPLETED
Allergic Rhinitis; Mild Asthma
University of North Carolina, Chapel Hill
 2007-03 PHASE1
NCT01822405 UNKNOWN
Fibrosis
Hospital Universitario de Canarias
 2010-07 PHASE2
NCT00905918 COMPLETED
Colorectal Cancer
Rutgers, The State University of New Jersey
 2009-06 PHASE1
NCT00235716 COMPLETED
Alzheimer's Disease
US Department of Veterans Affairs
 2007-08 PHASE3
NCT00678834 COMPLETED
End Stage Cardiac Failure; Pulmonary Failure; End Stage Liver Disease; Morbid Obesity; Recalcitrant Epilepsy Requiring Surgery; Healthy Subjects
Chandan K Sen
 2006-03 EARLY_PHASE1
NCT00895115 COMPLETED
Prostate Cancer
University of Medicine and Dentistry of New Jersey
 2009-04 PHASE1
NCT01314443 COMPLETED
Endothelial Dysfunction
University of Connecticut
 2011-01 PHASE1; PHASE2
NCT00893724 UNKNOWN
Neovascular Age-related Macular Degeneration; Diabetic Macular Edema
Mid-Atlantic Retina Consultations, Inc.
 2009-06
NCT01597765 COMPLETED
Thalassemia
Mahidol University
 2009-06
NCT01574313 COMPLETED
Vertigo; Meniere Disease
Chi Mei Medical Hospital
 2010-04 PHASE4
NCT00836368 COMPLETED
Allergic; Asthmatic; Allergy; Asthma
University of North Carolina, Chapel Hill
 2008-12 PHASE1
NCT01061320 UNKNOWN
Contrast Induced Nephropathy
Thammasat University
 2010-01 PHASE3
NCT01594346 COMPLETED
Alzheimer's Disease; Down Syndrome
New York State Institute for Basic Research
 2000-09 PHASE3
NCT01544192 COMPLETED
Glaucoma
Bagcilar Training and Research Hospital
 2008-04 PHASE3
NCT00631085 COMPLETED
Healthy
University of North Carolina, Chapel Hill
 2008-05 PHASE1
NCT00142610 COMPLETED
Asthma
University of North Carolina, Chapel Hill
 2005-08 PHASE1
NCT00281307 TERMINATED
Rhinitis
Milton S. Hershey Medical Center
 2005-12-07
NCT00386178 COMPLETED
Asthma
University of North Carolina, Chapel Hill
 2006-10 PHASE1
NCT00655018 COMPLETED
Inflammation; Fibrosis; Insulin Resistance
Bambino Gesù Hospital and Research Institute
 2003-01 PHASE2; PHASE3
NCT00002586 COMPLETED
Drug Toxicity; Lung Cancer
University of Colorado, Denver
 1993-01 PHASE2
NCT00219466 COMPLETED
Diaper Rash
Johnson & Johnson Consumer and Personal Products Worldwide
 2005-06 PHASE4
NCT00169845 COMPLETED
Neoplasms
Laval University
 1994-10 PHASE3
NCT00114387 COMPLETED
Atherosclerosis
National Institute on Aging (NIA)
 1996-07 PHASE2; PHASE3
NCT01422317 COMPLETED
Coronary Disease; Myocardial Infarction
Helse Stavanger HF
 1995-09 PHASE3
NCT00188669 TERMINATED
Breast Neoplasms
University Health Network, Toronto
 2002-07 PHASE2
NCT00162526 WITHDRAWN
Oral Mucositis
Hadassah Medical Organization
 2005-12 PHASE2
NCT00119119 TERMINATED
Hepatitis C, Chronic; Liver Fibrosis
French National Agency for Research on AIDS and Viral Hepatitis
 2002-02 PHASE3
NCT00003599 WITHDRAWN
Lung Cancer
M.D. Anderson Cancer Center
 PHASE3
NCT00022204 COMPLETED
Breast Cancer; Lymphedema
Royal Marsden NHS Foundation Trust
 2000-01 PHASE2
NCT00188552 TERMINATED
Wounds and Injuries
University Health Network, Toronto
 2002-07 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-08-06)

Check the (±)-α-Tocopherol product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a lipid-soluble antioxidant, (±)-α-tocopherol embeds within biological membranes to scavenge reactive oxygen species and inhibit lipid peroxidation cascades, thereby protecting cellular membrane integrity from oxidative damage. This membrane-stabilizing action mitigates oxidative stress-induced cellular injury, providing a physiological basis for its clinical evaluation in cardiovascular diseases, ischemia-reperfusion injury, and nutrient deficiency disorders.

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.