Clinical Trials

Numerous clinical trials spanning Phase 1 through Phase 4, alongside observational studies, evaluate Vitamin B12 across a wide spectrum of indications, including deficiency, gestational diabetes, generalized anxiety disorder, postoperative cognitive dysfunction, and chronic hepatitis C infection. Sponsored primarily by global academic and medical research institutions, these active and historic studies encompass various recruitment statuses—from recruiting to completed or terminated—and examine targeted areas such as maternal nutritional intake and post-surgical cognitive outcomes.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06966856 NOT_YET_RECRUITING
Hypovitaminosis b 12
Tanta University
2026-12-30 PHASE3
NCT04150042 RECRUITING
Pancreatic Adenocarcinoma Metastatic; BRCA1 Mutation; BRCA2 Mutation; Pancreatic Acinar Cell Carcinoma; Pancreatic Ductal Adenocarcinoma; Pancreatic Cancer; Metastatic Pancreatic Cancer; Metastatic Pancreatic Ductal Adenocarcinoma; Breast Cancer Metastatic; Breast Cancer Stage IV; Pancreatic Cancer Stage IV; HER2-negative Breast Cancer; HER2 Negative Breast Carcinoma; Adenocarcinoma of the Breast; PALB2 Gene Mutation; Pancreas Cancer, Metastatic; Pancreas Cancer, Recurrent; Pancreas Cancer; Stage IV Pancreatic Cancer; Stage 4 Pancreatic Cancer
General Oncology, Inc.
2021-01-13 PHASE1
NCT07697196 NOT_YET_RECRUITING
HPV Infection; HPV Integration; HPV Disease; HPV Genital Infection; HPV Persistence; Low Grade Squamous Intraepithelial Lesions of the Cervix
IRCCS San Raffaele
2026-07
NCT07344337 NOT_YET_RECRUITING
HPV Infection; Infertilities
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
2026-03
NCT07320183 NOT_YET_RECRUITING
HPV - Anogenital Human Papilloma Virus Infection; Infertilities
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
2026-03-01
NCT05796401 RECRUITING
Psychosis
Centre Hospitalier St Anne
2023-12-15 PHASE3
NCT07665671 RECRUITING
Healthy Volunteers
RDC Clinical Pty Ltd
2026-07-20 PHASE4
NCT07443410 RECRUITING
Periodontitis, Adult; Periodontitis (Stage 3); Periodontitis Stage IV
University Hospital Heidelberg
2024-10-25
NCT07781020 COMPLETED
Vitamin B12 Deficiency; Renal Failure , Chronic; Renal Dialysis
Jinnah Hospital
2026-02-22
NCT07341789 ENROLLING_BY_INVITATION
Vitamin b12; Supplementation During Endurance Performance; Flavonoids; Mental Fatigue; Biomarker Feedback
Francisco Javier Martínez Noguera
2025-12-01
NCT07486141 ACTIVE_NOT_RECRUITING
Mild Cognitive Impairment
Capital Medical University
2024-11-01
NCT06654154 RECRUITING
Level of Serum Vitamin B12 Level (in Pmol/L) If Relapse of (AI/ID) Under Tocilizumab; Level of Serum Vitamin B12 Level (in Pmol/L) If Infection Under Tocilizumab
University Hospital, Clermont-Ferrand
2024-04-03
NCT06285357 RECRUITING
HPV Infection
Lo.Li.Pharma s.r.l
2024-02-19
NCT06749756 RECRUITING
Septic Shock
Fan Zeng
2025-02-10
NCT07004465 COMPLETED
Mouth Ulcer
Hawraa Ali Abdullah
2025-08-19
NCT07793838 COMPLETED
Polycystic Ovary Syndrome (PCOS) Women
Jerash Private University
2025-08-01 PHASE4
NCT07048860 RECRUITING
Ageing
University Hospital, Toulouse
2025-07-09
NCT06772220 RECRUITING
Parkinson&Amp;#39;s Disease
Oregon Health and Science University
2024-03-05
NCT05751187 ACTIVE_NOT_RECRUITING
Non-squamous NSCLC
Shanghai Chest Hospital
2023-06-27 PHASE2
NCT06983223 COMPLETED
Vitamin B 12 Deficiency; Type 2 Diabetes Mellitus (T2DM)
Liaquat University of Medical & Health Sciences
2025-08-15
NCT05005897 RECRUITING
Vitamin B 12 Deficiency
Sykehuset Innlandet HF
2021-12-08 PHASE2; PHASE3
NCT07029698 COMPLETED
Vitamin B12 Deficiency
Medice Arzneimittel Pütter GmbH & Co KG
2025-04-16 PHASE4
NCT05785585 RECRUITING
Vitamin B12 Nutritional Deficiency
Fundació Eurecat
2023-09-09
NCT05385042 COMPLETED
Pregnancy Related
University of Oxford
2022-06-18
NCT04456985 UNKNOWN
Delirium
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
2020-06-01
NCT05740462 UNKNOWN
Iron Deficiency (Without Anemia); B12 Deficiency Vitamin
Quadram Institute Bioscience
2023-05-04
NCT06632470 NOT_YET_RECRUITING
Dementia; Moderate Dementia
Baermed
2024-10-15 PHASE1
NCT06443593 UNKNOWN
Type 1 Diabetes
Hirabai Cowasji Jehangir Medical Research Institute
2024-02-08
NCT07022938 COMPLETED
Cancer; Neuropathy; Chemotherapy Induced Pain Neuropathy; Chemotherapy-Induced Peripheral Neuropathy
Aristotle University Of Thessaloniki
2021-11-01 PHASE4
NCT06186154 UNKNOWN
Mitochondrial DNA Deletion; Macrocytosis
University of British Columbia
2024-01 PHASE1
NCT06046703 Not yet recruiting
Vitamin B 12 Deficiency|Pregnancy|Nutrient Deficiency|Dietary Exposure
Maastricht University Medical Center
2025-01-01 --
NCT04205786 WITHDRAWN
HR-positive Breast Cancer
Case Comprehensive Cancer Center
2021-08-12
NCT05423028 UNKNOWN
Carpal Tunnel Syndrome
National Cheng-Kung University Hospital
2021-12-07
NCT03853304 UNKNOWN
Anemia; Folate Deficiency; Vitamin B 12 Deficiency
Cornell University
2023-10-01
NCT06639789 RECRUITING
Performance Enhancing Product Use
Francisco Javier Martínez Noguera
2024-07-01
NCT04343170 COMPLETED
Ultra-short-term; Iron Deficiency Anemia; Scoliosis Idiopathic
Tanta University
2023-09-01
NCT06100146 COMPLETED
Folate Deficiency; Vitamin B 12 Deficiency; Anemia, Megaloblastic; Cognitive Development; Depressive Symptoms
University Ghent
2023-12-11
NCT06376591 COMPLETED
Vitamin B 12 Deficiency
Liaquat University of Medical & Health Sciences
2024-04-12
NCT04310059 Not yet recruiting
Thalassemia|Folic Acid Deficiency Anemia
The University of Hong Kong|Queen Mary Hospital Hong Kong
2024-07-01 Not Applicable
NCT06098456 COMPLETED
Papilloma-induced Cervical Lesions
Centro di Ricerca Clinica Salentino
2023-11-01 PHASE2
NCT06218030 Not yet recruiting
Generalized Anxiety Disorder
Queen''s University
2024-04 Phase 4
NCT05426395 ACTIVE_NOT_RECRUITING
Vitamin B 12 Deficiency
George Washington University
2023-06-05 PHASE1
NCT04786964 TERMINATED
Metastatic Non-squamous Non Small Cell Lung Cancer
Checkpoint Therapeutics, Inc.
2021-12-08 PHASE3
NCT06096298 UNKNOWN
Vitamin B12 Absorption
University of Helsinki
2023-10
NCT05931965 COMPLETED
Depression
Riphah International University
2022-10-05
NCT06241638 COMPLETED
Diabetes Mellitus
Al-Balqa Applied University
2022-07-01
NCT05614960 COMPLETED
Vitamin B 12 Deficiency
Fu Jen Catholic University
2022-11-07
NCT05289908 COMPLETED
Leptomeningeal Metastases
The First Hospital of Jilin University
2022-02-21 PHASE1; PHASE2
NCT03783091 COMPLETED
Septic Shock
Medical College of Wisconsin
2019-08-05 PHASE2
NCT05958277 COMPLETED
Traumatic Brain Injury
KRL Hospital, Islamabad
2021-06-01 PHASE3
NCT05625308 COMPLETED
Papilloma; Cervix Lesion
Lo.Li.Pharma s.r.l
2022-07-01
NCT05097365 ENROLLING_BY_INVITATION
Overweight and Obesity; Lupus Erythematosus
University of Sao Paulo
2022-01-01
NCT05260593 UNKNOWN
Carpal Tunnel Syndrome
October 6 University
2022-03-16
NCT03071666 ACTIVE_NOT_RECRUITING
Pregnancy Related; Vitamin B 12 Deficiency; Anemia
Centre For International Health
2017-03-27 PHASE2; PHASE3
NCT03735316 TERMINATED
Vasoplegic Syndrome
Mayo Clinic
2019-04-25 PHASE2
NCT04265534 TERMINATED
Non-Small Cell Lung Cancer; Non-squamous Non-small-cell Lung Cancer; Non-Squamous Non-Small Cell Neoplasm of Lung; KEAP1 Gene Mutation; NRF2 Gene Mutation; NFE2L2 Gene Mutation
Calithera Biosciences, Inc
2020-07-24 PHASE2
NCT03626922 UNKNOWN
Metastatic Colorectal Cancer
NSABP Foundation Inc
2019-05-15 PHASE1
NCT03258385 COMPLETED
Early Pregnancy
International Centre for Diarrhoeal Disease Research, Bangladesh
2017-09-01
NCT04395768 UNKNOWN
COVID19
National Institute of Integrative Medicine, Australia
2020-09-09 PHASE2
NCT03485404 TERMINATED
Post Operative Cognitive Dysfunction
Xijing Hospital
2019-01-10
NCT04627181 UNKNOWN
Iron Deficiency Anemia; B12 Deficiency Anemia
Christian Medical College, Vellore, India
2020-11-18 PHASE4
NCT04235426 UNKNOWN
Carpal Tunnel
Dalia Salah Saif
2018-01-26 PHASE1
NCT04404751 COMPLETED
Anemia
Haydom Lutheran Hospital
2019-08-23
NCT03887169 COMPLETED
Pulmonary Alveolar Proteinosis; Mutation Ala393Thr of the MARS Gene; mutationSer567Leu of the MARS Gene
Assistance Publique - Hôpitaux de Paris
2019-09-16 PHASE1; PHASE2
NCT04355949 COMPLETED
Vitamin D, Vitamin B12 and Folic Acid Among Patients With Premature Ejaculation
Sohag University
2020-02-28
NCT03802422 WITHDRAWN
Carpal Tunnel Syndrome
Tri-Service General Hospital (TSGH)
2019-04-20
NCT04706377 COMPLETED
Diabetes Mellitus; Diabetic Neuropathies; Diabetic Complication; Diabetic Foot
Aristotle University Of Thessaloniki
2018-02-01
NCT03778008 UNKNOWN
Stomatitis
Second Affiliated Hospital of Nanchang University
2018-12-21 PHASE2
NCT03193788 UNKNOWN
Bladder Cancer; Ureter Cancer; Transitional Cell Carcinoma
Asan Medical Center
2017-01 PHASE3
NCT05993962 COMPLETED
Vitamin B 12 Deficiency
University of British Columbia
2019-01-10
NCT04085354 COMPLETED
Premature Ejaculation
Sohag University
2019-02-10 PHASE3
NCT03950674 COMPLETED
Non-Small-Cell Lung Carcinoma
Merck Sharp & Dohme LLC
2016-02-22 PHASE3
NCT03384862 COMPLETED
Arsenic Exposure
Columbia University
2018-01-27
NCT03437824 COMPLETED
Vitamin B 12 Deficiency
University of Southern California
2017-10-01 EARLY_PHASE1
NCT03864198 UNKNOWN
Male Infertility
University Of Perugia
2019-01-20
NCT03593304 COMPLETED
Vincristine Induced Neurotoxicity; Acute Lymphoblastic Leukaemia
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
2018-03-29 PHASE2; PHASE3
NCT01500785 TERMINATED
Myocardial Stunning
Tampere University Hospital
2018-06-15 PHASE4
NCT03372447 COMPLETED
Megaloblastic Anemia Nos; Pernicious Anemia
Hospital Universitario Dr. Jose E. Gonzalez
2017-12-27 PHASE4
NCT03825042 COMPLETED
Cognitive Dysfunction
A. Menarini Industrie Farmaceutiche Riunite S.r.l.
2018-01-23
NCT04027959 COMPLETED
Macrocytic Anemia With Vitamin B12 Deficiency
James J. Peters Veterans Affairs Medical Center
2017-10-05
NCT02106650 COMPLETED
Relapsed Peripheral T-Cell Lymphoma; Refractory Peripheral T-Cell Lymphoma
Acrotech Biopharma Inc.
2014-07 PHASE2
NCT03101579 COMPLETED
Leptomeningeal Metastases
The First Hospital of Jilin University
2017-03-01 PHASE1
NCT02916121 UNKNOWN
Schizophrenia
Taipei Medical University WanFang Hospital
2016-10
NCT02923388 COMPLETED
Vincristine Induced Peripheral Neuropathy (VIPN)
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
2016-10 PHASE4
NCT02272842 UNKNOWN
Development; Vitamin Deficiency; Malnutrition
Centre For International Health
2015-04-20 PHASE2; PHASE3
NCT02031289 COMPLETED
Anemia; Iron Deficiency
University of Zurich
2013-12 PHASE4
NCT01476007 COMPLETED
Vitamin B 12 Deficiency
Gerencia de Atención Primaria, Madrid
2014-07
NCT02578680 COMPLETED
Non-Small-Cell Lung Carcinoma
Merck Sharp & Dohme LLC
2016-01-15 PHASE3
NCT02795572 TERMINATED
Peripheral Neuropathy in Breast Cancer Patient
AHS Cancer Control Alberta
2017-06-27 PHASE2
NCT02786823 COMPLETED
Diabetes Mellitus, Type 2
All India Institute of Medical Sciences, Bhubaneswar
2017-05-01 PHASE2; PHASE3
NCT03349333 COMPLETED
Refractory Peripheral T-Cell Lymphoma; Relapsed T-Cell Lymphoma
Mundipharma (China) Pharmaceutical Co. Ltd
2015-09-10 PHASE3
NCT03408639 COMPLETED
Anemia in End-Stage Renal Disease
Cinnagen
2016-06-22 PHASE3
NCT03844958 COMPLETED
Healthy
Zhejiang University
2017-06-15
NCT02735317 UNKNOWN
Nasopharyngeal Neoplasms; Stomatitis
Yun-fei Xia
2016-04 PHASE2
NCT00655980 COMPLETED
Major Surgery; Coronary Artery Disease
Washington University School of Medicine
2008-02
NCT02679443 COMPLETED
Lung Adenocarcinoma; Neutropenia; Anemia; Thrombocytopenia; Nonsquamous Nonsmall Cell Neoplasm of Lung
Post Graduate Institute of Medical Education and Research, Chandigarh
2015-07
NCT03069313 COMPLETED
Relief of Joint Pain
Texas Tech University Health Sciences Center, El Paso
2015-10-19
NCT01188876 COMPLETED
Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cancer
Massachusetts General Hospital
2010-08 PHASE1; PHASE2
NCT01317849 WITHDRAWN
Stroke; Transient Ischemic Attack
Xijing Hospital
2011-07
NCT02270749 COMPLETED
Vitamin B12 Deficiency
Rijnstate Hospital
2014-10 PHASE4
NCT02120274 TERMINATED
RNA Virus Infections; Flaviviridae Infections; Hepatitis C; Hepatitis C, Chronic
Federal University of São Paulo
2014-03 PHASE4
NCT02832726 COMPLETED
Healthy
University of Aarhus
2014-01
NCT02457507 COMPLETED
Cognitive Decline
Chinese University of Hong Kong
2011-08 PHASE4
NCT02679833 COMPLETED
Cobalamin Deficiency
Universität des Saarlandes
2014-11
NCT01832129 COMPLETED
Vitamin B 12 Deficiency
University Hospital, Basel, Switzerland
2013-05 PHASE4
NCT02013362 COMPLETED
Peripheral T-cell Lymphoma
Mundipharma K.K.
2014-03 PHASE1; PHASE2
NCT01134341 COMPLETED
Cutaneous T-cell Lymphoma; Mycosis Fungoides; Sezary Syndrome; Primary Cutaneous Anaplastic Large Cell Lymphoma
Acrotech Biopharma Inc.
2010-03 PHASE1
NCT03903952 COMPLETED
ASC-US; Human Papilloma Virus
Sanliurfa Mehmet Akif Inan Education and Research Hospital
2014-05-01
NCT02540642 COMPLETED
Type 2 Diabetes; Vitamin B12 Deficiency; Hyperhomocysteinemia
Smt. Kashibai Navale Medical College and General Hospital
2010-10
NCT01953757 COMPLETED
Diabetic Neuropathy
Physicians Committee for Responsible Medicine
2013-09
NCT01127724 TERMINATED
Recurrent Aphthous Stomatitis
Meir Medical Center
2012-06
NCT02076347 COMPLETED
Type 2 Diabetes; Vitamin B12 Deficiency; Neuropathy; Anemia
Ohio State University
2014-02
NCT01921192 UNKNOWN
Non Proliferative Diabetic Retinopathy; Proliferative Diabetic Retinopathy
University of Catania
2012-09 PHASE4
NCT01806272 UNKNOWN
Nasopharyngeal Cancers
Wei LUO
2013-03 PHASE2
NCT01569919 UNKNOWN
Malignant; Pleural; Mesothelioma
Wales Cancer Trials Unit
2012-12 PHASE2
NCT01661309 COMPLETED
Vitamin B12 Deficiency
University of West London
2012-03
NCT01183065 COMPLETED
Head and Neck Cancer
Memorial Sloan Kettering Cancer Center
2010-08 PHASE2
NCT01690962 COMPLETED
Diabetic Neuropathy
Physicians Committee for Responsible Medicine
2012-11
NCT01475617 COMPLETED
Bariatric Surgery Candidate
Yasoo Health
2011-11 PHASE2; PHASE3
NCT01165021 COMPLETED
Non Small Cell Lung Cancer
Eli Lilly and Company
2010-11 PHASE2
NCT00659269 COMPLETED
Cancer
New Mexico Cancer Research Alliance
2006-07 PHASE3
NCT00923273 TERMINATED
Carcinoma, Non-Small-Cell Lung
National Cancer Institute (NCI)
2008-02-29 PHASE1; PHASE2
NCT00696514 UNKNOWN
Osteoporosis; Cognitive Decline
Wageningen University
2008-09 PHASE1
NCT01762072 UNKNOWN
Healthy
Zhejiang University
2013-01
NCT01474044 COMPLETED
Chronic Atrophic Gastritis (CAG)
Xinjiang Biochemical Pharmaceutical Co., Ltd.
2011-08 PHASE4
NCT03522428 COMPLETED
Pregnancy Anemia
Mirela Zec
2011-09-15 PHASE4
NCT01490944 UNKNOWN
Anaemia
Indian Council of Medical Research
2012-01 PHASE2
NCT00998946 COMPLETED
Lymphoma, B-Cell
Spectrum Pharmaceuticals, Inc
2009-09 PHASE2
NCT01795131 COMPLETED
Nutritional Anemia in Mothers.; Nutritional Anemia in Infants.
International Centre for Diarrhoeal Disease Research, Bangladesh
2010-02 PHASE2; PHASE3
NCT01118624 COMPLETED
Breast Cancer; Breast Tumors; Neoplasms, Breast; Cancer of the Breast; Human Mammary Carcinoma
Acrotech Biopharma Inc.
2010-03 PHASE2
NCT01057589 COMPLETED
Head and Neck Neoplasms
Eli Lilly and Company
2010-02 PHASE2
NCT00554827 COMPLETED
Cutaneous T-cell Lymphoma
Acrotech Biopharma Inc.
2007-08 PHASE1
NCT00835731 COMPLETED
Cervical Ripening
Planned Parenthood League of Massachusetts
2009-01
NCT01297361 COMPLETED
Vitamin B12 Deficiency; Folic Acid Deficiency
Meir Medical Center
2011-02
NCT00717730 COMPLETED
Diarrhea; Pneumonia
Tor A. Strand
2010-01 PHASE2
NCT00481871 COMPLETED
Relapsed or Refractory Lymphoproliferative Malignancies; Hodgkin's Lymphoma; Peripheral T-cell Lymphoma; B-cell Lymphoma; Waldenstrom's Macroglobulinemia
Acrotech Biopharma Inc.
2007-05 PHASE1; PHASE2
NCT00541073 COMPLETED
Malignant Mesothelioma
Centre Oscar Lambret
2007-06 PHASE2
NCT01306123 COMPLETED
Focus: Bioavailability
Swedish Orphan Biovitrum
2011-02 PHASE1
NCT01876732 COMPLETED
Vitamin B12 Deficiency
Northwell Health
2009-06
NCT00722553 COMPLETED
Carcinoma, Transitional Cell; Bladder Cancer; Bladder Neoplasm
Acrotech Biopharma Inc.
2008-07 PHASE2
NCT00730574 TERMINATED
B12 Deficiency Combined With C677T Mutation on MTHFR Gene
Moshe Flugelman
2008-07
NCT00641862 COMPLETED
Pregnancy
Harvard School of Public Health (HSPH)
2008-12
NCT00214682 COMPLETED
Depression; Depressive Disorder
Australian National University
2005-10 PHASE2
NCT00326833 UNKNOWN
Vitamin B12 Deficiency
University of Aarhus
2006-01 PHASE4
NCT00227019 COMPLETED
Non-small Cell Lung Cancer (NSCLC); Lung Cancer; Neoplasm Metastasis
Heather Wakelee
2006-03 PHASE2
NCT01194453 COMPLETED
Non-small Cell Lung Cancer; Efficacy
Sun Yat-sen University
2009-11 PHASE2
NCT00710359 COMPLETED
Vitamin B 12 Deficiency
Haukeland University Hospital
2008-04
NCT00710138 COMPLETED
Vitamin B 12 Deficiency
Haukeland University Hospital
2008-06
NCT00606502 COMPLETED
Non-small Cell Lung Cancer
Spectrum Pharmaceuticals, Inc
2008-01 PHASE2
NCT00853879 TERMINATED
Parkinson's Disease
Northwell Health
2006-12
NCT00939718 UNKNOWN
Major Depressive Disorder
Aga Khan University
2009-04
NCT00348933 COMPLETED
Angelman Syndrome; Nervous System Diseases
University of California, San Diego
2006-07
NCT00208611 TERMINATED
Parkinson's Disease
Emory University
2006-09 PHASE2; PHASE3
NCT00901394 COMPLETED
Cardiovascular Abnormalities
Washington University School of Medicine
2009-03
NCT00609518 COMPLETED
Non Small Cell Lung Cancer
Eli Lilly and Company
2008-02 PHASE2
NCT00730093 COMPLETED
Pregnancy
University of Aarhus
2008-08
NCT00216099 COMPLETED
Prostate Cancer
Christopher Sweeney, MBBS
2005-02 PHASE2
NCT00364923 COMPLETED
Peripheral T-cell Lymphoma
Acrotech Biopharma Inc.
2006-08 PHASE2
NCT00402883 TERMINATED
Lung Cancer
SCRI Development Innovations, LLC
2006-11 PHASE2
NCT00164970 COMPLETED
Dementia
Chinese University of Hong Kong
2004-10 PHASE4
NCT00699478 COMPLETED
Vitamin B12 Deficiency
Yonsei University
2008-04 PHASE2
NCT00124072 COMPLETED
Cardiovascular Disease
University of Oxford
1998-07 PHASE3
NCT00843453 COMPLETED
Vitamin B12 Deficiency
University of Delaware
2006-11
NCT00288769 COMPLETED
Recurrent Aphthous Stomatitis
Soroka University Medical Center
2006-03
NCT00120484 COMPLETED
Sleep Disorders, Circadian Rhythm
Brigham and Women's Hospital
2005-04
NCT00354081 COMPLETED
Coronary Artery Disease; Myocardial Infarction; Cerebrovascular Stroke
Haukeland University Hospital
1999-04 PHASE3
NCT00056225 COMPLETED
Alzheimer's Disease
National Institute on Aging (NIA)
2003-01 PHASE3
NCT00693589 COMPLETED
Cardiovascular Disease; Endothelial Dysfunction
Insel Gruppe AG, University Hospital Bern
2005-01 PHASE2
NCT00114400 COMPLETED
Atherosclerosis
National Institute on Aging (NIA)
2000-11 PHASE2; PHASE3
NCT04731948 COMPLETED
Healthy
University of Ulster
2004-10-01
NCT00202280 COMPLETED
First Episode Psychosis
Melbourne Health
2004-09 PHASE2; PHASE3
NCT00479479 COMPLETED
Vitamin B 12 Deficiency
Haukeland University Hospital
2004-12
NCT00235573 COMPLETED
Disorder of Vitamin B12
University of Florida
2005-10
NCT00826657 COMPLETED
Vitamin B12 Deficiency
USDA, Western Human Nutrition Research Center
2004-10
NCT00000541 COMPLETED
Cardiovascular Diseases; Coronary Arteriosclerosis; Coronary Disease; Heart Diseases; Myocardial Infarction; Myocardial Ischemia
Brigham and Women's Hospital
1993-05 PHASE2
NCT00353353 COMPLETED
Healthy
Wageningen Centre for Food Sciences
2006-07
NCT00165711 COMPLETED
Dementia With Vitamin B12 Deficiency
Eisai Co., Ltd.
2003-03 PHASE4
NCT00266487 COMPLETED
Acute Myocardial Infarction
University of Tromso
1998-12
NCT00279552 COMPLETED
Vitamin B12 Deficiency
University of Aarhus
2004-04 PHASE2
NCT01312831 COMPLETED
Vitamin B 12 Deficiency
Emisphere Technologies, Inc.
2009-02
NCT00730509 COMPLETED
Cystic Fibrosis
Universita di Verona
2004-04
NCT00306358 COMPLETED
Vitamin B12 Absorption
University of Aarhus
2005-05
NCT00111267 COMPLETED
Cognitive Decline; Cognitive Symptoms
Wageningen University
2003-05
NCT00403247 COMPLETED
Schizophrenia; Schizoaffective Disorder
Nathan Kline Institute for Psychiatric Research
2004-07
NCT00350116 COMPLETED
Chronic Plaque Psoriasis
Ruhr University of Bochum
2001-01 PHASE3

(data from https://clinicaltrials.gov, updated on 2025-05-13)

Check the Vitamin B12 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Vitamin B12 functions as a critical enzymatic cofactor for methionine synthase and methylmalonyl-CoA mutase, driving essential downstream biochemical pathways involved in one-carbon metabolism, DNA synthesis, and mitochondrial fatty acid conversion. By supporting nucleic acid maturation and neuronal myelin sheath integrity at the cellular level, cobalamin-mediated signaling maintains physiological neurological function and hematopoiesis, which directly connects to its therapeutic evaluation in clinical conditions such as Vitamin B12 deficiency and cognitive decline.

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.