Clinical Trials

Numerous clinical trials evaluate thiamine HCl across diverse indications, including thiamine deficiency, critical illness, sepsis, septic shock, type 2 diabetes, and cardiovascular conditions. Primarily sponsored by academic medical centers such as Emory University and the University of California, Los Angeles, these studies span Early Phase 1 through Phase 4 interventions. Displaying recruitment statuses ranging from active recruiting to completed and terminated, these trials explore targeted applications such as combination metabolic therapies in sepsis and evaluations of pediatric cardiac markers.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07793071 NOT_YET_RECRUITING
Major Depressive Disorder (MDD); Thiamine; Vitamin B1; Thiamine Diphosphate (TDP); Pediatrics
Massachusetts General Hospital
 2026-10-01 PHASE2
NCT07795996 RECRUITING
Neurocognition, Child
Mount Saint Vincent University
 2026-06-01
NCT06649825 ENROLLING_BY_INVITATION
Familial Adenomatous Polyposis (FAP)
Shanghai Zhongshan Hospital
 2024-01-08
NCT06959251 RECRUITING
Primary Ciliary Dyskinesia
Instituto Nacional de Enfermedades Respiratorias
 2025-10-02
NCT05817851 RECRUITING
Cardiac Arrest
Centre Hospitalier de Bethune
 2023-12-27 PHASE2
NCT07708233 RECRUITING
Diabetic Peripheral Neuropathy (DPN)
Thammasat University
 2026-07-14 PHASE4
NCT05873881 RECRUITING
Heart Failure
Hamilton Health Sciences Corporation
 2024-01-29 PHASE3
NCT07046429 RECRUITING
Hepatic Encephalopathy; Covert Hepatic Encephalopathy; Cirrhosis; Sleep Disturbances and Insomnia
Weill Medical College of Cornell University
 2025-08-05
NCT06322212 RECRUITING
Type2diabetes
University of California, Los Angeles
 2024-08-01 EARLY_PHASE1
NCT07312123 RECRUITING
Carpal Tunnel Syndrome
Hospital Universiti Sains Malaysia
 2025-12-08
NCT07665658 RECRUITING
Attention Deficit Hyperactivity Disorder
Khyber Medical University Peshawar
 2026-03-01
NCT07475299 NOT_YET_RECRUITING
Irritable Bowel Syndrome (IBS)
Iuliu Hatieganu University of Medicine and Pharmacy
 2026-04
NCT06326996 RECRUITING
Coronary Heart Disease; Coronary Artery Bypass Grafting
University of California, Los Angeles
 2024-10-10 EARLY_PHASE1
NCT06298344 COMPLETED
Congenital Heart Disease; Thiamine Deficiency; Patent Ductus Arteriosus; Ventricular Septal Defect; Atrial Septal Defect
Universitas Sumatera Utara
 2024-05-01 EARLY_PHASE1
NCT06723626 RECRUITING
Septic Shock
Southeast University, China
 2024-07-01
NCT05385042 COMPLETED
Pregnancy Related
University of Oxford
 2022-06-18
NCT04478734 RECRUITING
Huntington Disease
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
 2023-04-12 PHASE2
NCT07022938 COMPLETED
Cancer; Neuropathy; Chemotherapy Induced Pain Neuropathy; Chemotherapy-Induced Peripheral Neuropathy
Aristotle University Of Thessaloniki
 2021-11-01 PHASE4
NCT05638633 COMPLETED
Post-COVID-19 Syndrome
Wuerzburg University Hospital
 2022-11-11 PHASE3
NCT04921189 COMPLETED
Out-Of-Hospital Cardiac Arrest; Postcardiac Arrest Syndrome
Asan Medical Center
 2021-12-31 PHASE2
NCT03717896 COMPLETED
Diabetic Ketoacidosis
Beth Israel Deaconess Medical Center
 2018-11-21 PHASE2
NCT05642923 COMPLETED
Post-COVID-19 Syndrome; Post-COVID Syndrome
ClinAmygate
 2023-01-08 PHASE4
NCT06298344 Recruiting
Congenital Heart Disease|Thiamine Deficiency|Patent Ductus Arteriosus|Ventricular Septal Defect|Atrial Septal Defect
Universitas Sumatera Utara
 2024-05-01 Early Phase 1
NCT06326996 Not yet recruiting
Coronary Heart Disease|Coronary Artery Bypass Grafting
University of California Los Angeles
 2024-05 Not Applicable
NCT06322212 Not yet recruiting
Type2diabetes
University of California Los Angeles
 2024-04 Not Applicable
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 --
NCT03509662 COMPLETED
Cardiac Arrest
Amsterdam UMC, location VUmc
 2019-10-07 PHASE2
NCT05971680 UNKNOWN
Intra-uterine Device Complication
Beni-Suef University
 2023-07-30 PHASE3
NCT03746106 COMPLETED
Vitamin B1 Deficiency; Thiamine Deficiency
University of California, San Francisco
 2019-01-28 PHASE4
NCT05157360 TERMINATED
Necrotizing Soft Tissue Infection; Sepsis
Ascension Health
 2021-09-10 PHASE1; PHASE2
NCT05221892 COMPLETED
Vertigo
Fundação Educacional Serra dos Órgãos
 2021-11-22 PHASE4
NCT05585346 COMPLETED
Bell's Palsy
Beijing Tongren Hospital
 2021-01-01
NCT03592693 TERMINATED
Shock, Septic
University of Athens
 2018-09-06 PHASE2
NCT03649633 TERMINATED
Septic Shock
University of Athens
 2018-09-06 PHASE1; PHASE2
NCT04893993 UNKNOWN
Primary Biliary Cirrhosis
Henning Grønbæk
 2021-05-12 PHASE4
NCT05663164 COMPLETED
Sepsis; Thiamine Deficiency
Universitas Sumatera Utara
 2022-10-01
NCT07450833 COMPLETED
Healthy Volunteers
Benfovir AG
 2022-03-01 PHASE1
NCT04641104 COMPLETED
Lactate Blood Increase; Thiamine Deficiency
Sarah Saxena
 2020-11-20 PHASE4
NCT04651205 SUSPENDED
Diet, Carbohydrate-restricted
University of Glasgow
 2021-10
NCT05192213 TERMINATED
Sepsis; Septic Shock
Hospital Sirio-Libanes
 2021-08-01 PHASE3
NCT03550794 COMPLETED
Sepsis; Kidney Injury; Thiamine Deficiency
Beth Israel Deaconess Medical Center
 2018-09-04 PHASE2
NCT03450707 TERMINATED
Cardiac Arrest
Michael Donnino
 2018-05-06 PHASE2
NCT02974257 TERMINATED
Cardiac Arrest; Shock; Lactic Acidosis; Thiamin Deficiency
Beth Israel Deaconess Medical Center
 2017-05-01 PHASE2
NCT04053621 UNKNOWN
Diabetes Mellitus, Type 2
Laboratorios Manuell SA
 2021-01
NCT04669119 UNKNOWN
Breast Cancer Female; Pain, Postoperative
University of Bari Aldo Moro
 2020-12-31 PHASE4
NCT04999137 UNKNOWN
Sepsis; Septic Shock; HIV
Liverpool School of Tropical Medicine
 2021-09-01 PHASE2
NCT04453761 UNKNOWN
Thiamine Deficiency; Congenital Heart Disease; Cardiopulmonary Bypass
National Cardiovascular Center Harapan Kita Hospital Indonesia
 2018-07-01 PHASE4
NCT03968042 UNKNOWN
Alcohol-induced Brain Injury
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
 2019-06-30 PHASE2
NCT03872011 COMPLETED
Septic Shock
Northern Jiangsu People's Hospital
 2019-02-19 PHASE3
NCT04160676 COMPLETED
Sepsis
Tanta University
 2019-12-01
NCT07786350 COMPLETED
Sepsis and Septic Shock
Universitas Sumatera Utara
 2020-04-01
NCT03228030 COMPLETED
Heart Failure; Heart Failure With Reduced Ejection Fraction; Thiamine Deficiency; Congestive Heart Failure
Hamilton Health Sciences Corporation
 2018-04-02 PHASE1
NCT03592277 COMPLETED
Sepsis; Septic Shock
Trinity Health Of New England
 2018-09-14 PHASE2
NCT04039815 UNKNOWN
Sepsis, Severe
Far Eastern Memorial Hospital
 2019-12-03 PHASE4
NCT04216459 COMPLETED
Major Trauma; Sepsis
Mansoura University
 2020-02-18
NCT04508946 COMPLETED
Septic Shock; Sepsis; Organ Dysfunction Syndrome Sepsis
Air Force Specialized Hospital, Cairo, Egypt
 2019-08-01 PHASE3
NCT04134403 UNKNOWN
Septic Shock
Baqiyatallah Medical Sciences University
 2019-12-01 PHASE3
NCT03432572 COMPLETED
Ureteral Injury
Texas Tech University Health Sciences Center
 2018-06-27 EARLY_PHASE1
NCT03989700 UNKNOWN
Heart Diseases
Mahidol University
 2019-07-01 PHASE3
NCT03616288 COMPLETED
Thiamine Deficiency
Mount Saint Vincent University
 2018-08-28
NCT03634735 COMPLETED
Fatigue
University of Aarhus
 2018-11-27 PHASE4
NCT03263442 COMPLETED
Hematopoietic Stem Cell Transplantation; Delirium; Thiamine Deficiency
UNC Lineberger Comprehensive Cancer Center
 2017-10-16 PHASE2
NCT03540628 COMPLETED
Septic Shock
Corewell Health South
 2018-02-26
NCT03828929 TERMINATED
Septic Shock
New York Presbyterian Brooklyn Methodist Hospital
 2019-10-15 PHASE3
NCT03756220 COMPLETED
Septic Shock; Sepsis
Tae Gun Shin
 2018-12-01 PHASE2
NCT03821714 COMPLETED
Septic Shock
Southeast University, China
 2019-02-01
NCT03389555 COMPLETED
Sepsis; Septic Shock; Metabolic Disturbance
Beth Israel Deaconess Medical Center
 2018-02-09 PHASE2; PHASE3
NCT03380507 TERMINATED
Septic Shock; Critical Illness
Hamad Medical Corporation
 2018-03-17 PHASE2; PHASE3
NCT03509350 COMPLETED
Sepsis
Emory University
 2018-08-22 PHASE3
NCT04137276 COMPLETED
Sepsis
Indonesia University
 2019-04-01
NCT03333278 COMPLETED
Shock, Septic; Critically Ill; Vasoplegic Syndrome; Sepsis
Australian and New Zealand Intensive Care Research Centre
 2018-05-02 PHASE2
NCT03422159 COMPLETED
Sepsis, Severe; Septic Shock
Community Medical Center, Toms River, NJ
 2018-02-05 PHASE2
NCT02788552 COMPLETED
Wernicke-Korsakoff Syndrome
Menzies School of Health Research
 2014-09 PHASE4
NCT04977557 COMPLETED
Dry Beriberi
Chittagong Medical College
 2018-11-11
NCT03122678 WITHDRAWN
Septic Shock; Shock, Septic; Lactic Acidosis; Thiamine Deficiency
The Cleveland Clinic
 2016-11-05 PHASE1
NCT03258684 COMPLETED
Sepsis
Zhujiang Hospital
 2017-09-25
NCT03341286 UNKNOWN
Cancer; Quality of Life; Chemotherapy Effect; Tryptophan; Thiamine
Faculdade de Medicina do ABC
 2017-11 PHASE2
NCT03649009 UNKNOWN
Hyperlactatemia
Universiti Kebangsaan Malaysia Medical Centre
 2018-01-01
NCT03335124 TERMINATED
Sepsis; Septic Shock; Critical Illness; Fluid Overload
University Medical Centre Ljubljana
 2017-09-26 PHASE4
NCT03372447 COMPLETED
Megaloblastic Anemia Nos; Pernicious Anemia
Hospital Universitario Dr. Jose E. Gonzalez
 2017-12-27 PHASE4
NCT03220113 UNKNOWN
Chronic Migraine Without Aura, Intractable; Migraine With Typical Aura; Migraine Disorders
Corona Doctors Medical Clinics, Inc.
 2017-07-01 PHASE1; PHASE2
NCT02464865 COMPLETED
Obesity; Child; Thiamine Deficiency
Mahidol University
 2015-08 PHASE4
NCT03306732 COMPLETED
Cardiac Surgery
Meshalkin Research Institute of Pathology of Circulation
 2017-10-19 PHASE4
NCT03466528 COMPLETED
Alcohol Withdrawal; Lactic Acidosis; Vitamin B1 Deficiency; Magnesium Deficiency; Wernicke Encephalopathy
Glasgow Royal Infirmary
 2016-12-16 PHASE2; PHASE3
NCT02767245 COMPLETED
Thyrotoxicosis
Ramathibodi Hospital
 2014-01
NCT01985685 COMPLETED
Critically Ill; Respiratory Failure
Beth Israel Deaconess Medical Center
 2013-10 PHASE2
NCT02054299 COMPLETED
Drug Metabolism; Membrane Transport
University Medical Center Goettingen
 2013-04 PHASE1
NCT01381354 COMPLETED
Multiple Sclerosis
University of Iowa
 2010-10 PHASE1
NCT00959075 COMPLETED
Heart Failure
Unity Health Toronto
 2009-09 PHASE4
NCT02322892 COMPLETED
Coronary Artery Bypass; Cardiac Surgical Procedures
Beth Israel Deaconess Medical Center
 2015-01 PHASE2
NCT02415777 COMPLETED
Fatigue
Daewoong Pharmaceutical Co. LTD.
 2014-10 PHASE4
NCT02418130 COMPLETED
Fatigue
Daewoong Pharmaceutical Co. LTD.
 2014-10 PHASE4
NCT01524315 COMPLETED
Heart Failure; Acidosis, Lactic; Thiamine Deficiency
Medical University of Vienna
 2012-02-01 PHASE4
NCT01070810 COMPLETED
Septic Shock
Beth Israel Deaconess Medical Center
 2010-02 PHASE1; PHASE2
NCT02087462 UNKNOWN
Sciatica Due to Intervertebral Disc Disorder
Chengdu University of Traditional Chinese Medicine
 2012-01
NCT01725412 UNKNOWN
Diabetic Nephropathy
University of Saskatchewan
 2012-11 PHASE4
NCT01462279 COMPLETED
Acute Respiratory Failure
Beth Israel Deaconess Medical Center
 2011-09
NCT01864057 COMPLETED
Beriberi
Mayo Clinic
 2012-01 PHASE1
NCT00861523 TERMINATED
Hyperemesis Gravidarum
HaEmek Medical Center, Israel
 2009-02 PHASE3
NCT01115504 COMPLETED
Chronic Heart Failure
Mashhad University of Medical Sciences
 2010-05 PHASE3
NCT01433952 COMPLETED
Pharmacokinetics in Healthy Subjects
Baystate Medical Center
 2009-06 PHASE1
NCT00680706 COMPLETED
Heart Failure; Diabetes
Baystate Medical Center
 2008-01 PHASE2
NCT00770107 COMPLETED
Heart Failure
Luzerner Kantonsspital
 2004-06
NCT00202228 COMPLETED
HIV Infections; AIDS; Lactic Acidosis; Lipodystrophy
Queen's University
 2002-07 PHASE4
NCT00143702 COMPLETED
Acidosis, Lactic
University of British Columbia
 2001-08 PHASE2; PHASE3
NCT00279266 WITHDRAWN
Peripheral Neuropathy; Diabetes Mellitus; Diabetes Complications
Loma Linda University
 2006-01
NCT00515736 TERMINATED
Critically Ill Patients; Cardiac Surgery; Trauma; Subarachnoid Hemorrhage
Centre Hospitalier Universitaire Vaudois
 2003-01 PHASE3
NCT00031057 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
NCT00037063 WITHDRAWN
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
NCT00562835 UNKNOWN
Acute Lung Injury; ARDS, Human
Catholic University of the Sacred Heart
 2008-02 PHASE2; PHASE3

(data from https://clinicaltrials.gov, updated on 2026-08-28)

Check the Thiamine HCl (Vitamin B1) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Thiamine HCl serves as an essential precursor for thiamine pyrophosphate, an vital coenzyme that binds and activates key metabolic enzymes such as pyruvate dehydrogenase and transketolase to facilitate mitochondrial ATP generation and glucose utilization. By restoring cellular bioenergetics and mitigating lactic acid accumulation, thiamine administration supports cellular homeostasis and tissue function in clinical conditions including thiamine deficiency, sepsis-induced metabolic dysfunction, and cardiovascular 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.