Last update 12 Dec 2024

Thiamine Hydrochloride

Last update 12 Dec 2024

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

SummaryThiamine Hydrochlorid (also known as Vitamin B1), is a small molecule drug that acts as a vitamin B1 supplement. Approved in December 1952, and is typically administered orally or intravenously.

Drug Type

Small molecule drug

Synonyms

Thiamine Chloride Hydrochloride, Thiamine chloride hydrochloride (JP17), Thiamine hydrochloride (USP)

+ [26]

Target-

Mechanism

Vitamin B1 supplements

Therapeutic Areas

Endocrinology and Metabolic Disease

Active Indication

Thiamine Deficiency

Inactive Indication-

Originator Organization

Takeda Pharmaceutical Co., Ltd.

Active Organization

Tianjin Jinyao Pharmaceutical Co., Ltd.

Takeda Pharmaceutical Co., Ltd.

Biological Therapies

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

JP (01 Dec 1952),

Thiamine Deficiency

Regulation-

Structure

Molecular FormulaC12H18Cl2N4OS

InChIKeyDPJRMOMPQZCRJU-UHFFFAOYSA-M

CAS Registry67-03-8

192

Clinical Trials associated with Thiamine Hydrochloride

IRCT20190224042815N1 / SuspendedPhase 2/3IIT

Evaluating the preventive effect of vitamin B1 on Delirium in critically ill patients

Start Date18 May 2640

Sponsor / Collaborator

Tehran University of Medical Sciences

NCT05083546 / Not yet recruitingPhase 1/2IIT

Testing the Impact of a Combination of Dietary Supplements With Multimodal Effects on Longevity Mechanisms on Reducing Body Weight and Delaying Aging

Mechanisms that drive addiction to sugar rich foods are a major driving factor in the pathogenesis of obesity, which has become one of the most significant health care burdens. The molecular underpinnings of these hedonic mechanisms that drive addiction to sugar are poorly understood. The investigators demonstrated that methylglyoxal (MGO) derived Advanced Glycation Endproducts (AGEs) enhance food intake especially under a high sugar diet. The investigators identified a methylglyoxal (MGO) lowering cocktail, Gly-low, a combination of alpha-lipoic acid, nicotinamide, thiamine, pyridoxamine, and piperine that demonstrates a multimodal effect influencing many pathways related to aging including calorie restriction. Glycation lowering (Gly-low) treatment significantly reduces food intake and weight gain in the db/db mice that lack the leptin receptor. The investigators also extended the lifespan of C57BL/6 mice fed with these compounds starting when they were 24 months old. Based on these results, the investigators hypothesized that methylglyoxal (MGO) lowering cocktail of compounds can be given to adults with obesity, specified as body mass index (BMI) >27, to lower serum and urinary markers of insulin resistance, lower boy mass index (BMI), and lower food intake.

Start Date01 Dec 2024

Sponsor / Collaborator

The University of California, San Francisco

CTRI/2024/09/073873 / Not yet recruitingPhase 2IIT

Non-Cardiac Pulmonary Arterial Hypertension in Infants Presenting with Respiratory Distress: Assessing the Efficacy of Thiamine Supplementation in a Clinical Setting - NIL

Start Date11 Nov 2024

Sponsor / Collaborator-

100 Clinical Results associated with Thiamine Hydrochloride

100 Translational Medicine associated with Thiamine Hydrochloride

100 Patents (Medical) associated with Thiamine Hydrochloride

9,495

Literatures (Medical) associated with Thiamine Hydrochloride

01 Feb 2025·Clinical Nutrition ESPEN

Dietary supplementation use for outpatient treatment in children: A cross-sectional study

Article

Author: Le Thi, Tuong Vi ; Pham, Em Canh ; Nguyen, Tien Minh ; Le, Thanh Chi ; Nguyen, Nam Tran

OBJECTIVE:

Dietary supplements (DSs) are commonly used supplements among children to support disease treatment, however, overuse and inappropriate prescription of outpatient DS can negatively affect health and treatment costs. This study aimed to evaluate DS use in outpatient treatment in children.

METHODS:

The present study used a cross-sectional descriptive retrospective method based on data from 188,579 outpatient prescriptions of children for 1 year.

RESULTS:

DSs were commonly prescribed in pediatric patients ≤5 years old (63.48 %) with diagnosing respiratory, infectious, and gastrointestinal diseases (>50 %). DS costs account for a high proportion (24.86 %) of total outpatient prescription costs. In addition, pediatric prescriptions containing one DS product (88.16 %) showed a higher rate than prescriptions containing two DS products (11.84 %) with the main ingredients being vitamin D₃ (80.55 %), vitamin B₆ (63.01 %), vitamin B₁ (60.22 %), and vitamin B₂ (59.04 %), and calcium (51.0 %). The majority of DS products contained multivitamins (69.52 %) with DS containing ≥5 vitamins of 59.04 % and DS containing 2-4 vitamins of 10.48 %. Besides, non-compliance with DS prescribing guidelines for age (21.38 %), dose (14.13 %), and both age and dose (5.54 %) was found primarily in highly prescribed DSs (vitamin-amino acid-mineral ingredients), pediatric patients <2 years old, prescriptions containing one DS product or multivitamins, and respiratory disease group (J and R04-09 ICD). The univariate and multivariate regression analyses showed that vitamin-mineral products and groups <2 years old were significantly associated with guideline-adherent DS prescribing for age and/or dose. Meanwhile, foreign DSs and vitamin-mineral ingredients of prescription showed significant associations with guideline-adherent DS prescribing for age or dose.

CONCLUSION:

Instructions for DS use regarding recommended age and maximum dosage may not be carefully considered by doctors due to belonging to an over-the-counter medicine group. Therefore, there is a strong need for a national public policy to prevent and control overprescribing and inappropriate prescribing of DS.

01 Jan 2025·AMERICAN JOURNAL OF HEALTH PROMOTION

Vitamin B12 Status in Vegan and Vegetarian Seventh-Day Adventists: A Systematic Review and Meta-Analysis of Serum Levels and Dietary Intake

Review

Author: Janko, Robert K. ; Patel, Ashok ; Haussmann, Irmgard

Objective:

This systematic review and meta-analysis aimed to evaluate the vitamin B12 status and intake of Seventh-day Adventists following a plant-based diet and compare it with omnivore controls to investigate their susceptibility for vitamin B12 deficiency.

Data Source:

Peer-reviewed articles were identified through a comprehensive search in PubMed, Scopus, and Google Scholar databases from inception up to the year 2024 using specific keywords related to vitamin B12 and Seventh-day Adventists.

Study Inclusion and Exclusion Criteria:

Observational studies published in the English language were included if they reported on vitamin B12 status or intake among plant-based Adventists and compared it with omnivore controls who may or may not have been Adventists. Studies that did not present distinguishable results for vegetarian/vegan from omnivore Adventists or only reported on food item intake without specific vitamin B12 data were excluded.

Data Extraction:

Two independent reviewers extracted data on study characteristics, vitamin B12 intake, and serum levels using a customised data extraction form, resolving discrepancies through consultation with a third reviewer.

Data Synthesis:

A meta-analysis was conducted using random-effect models due to anticipated heterogeneity, without any subgroup analysis due to the low number of studies. Sensitivity analysis was performed using the ‘leave-on-out’ method to assess individual study influence on overall effect size and heterogeneity.

Results:

Four studies met inclusion criteria, encompassing 1994 participants. Meta-analysis showed no significant differences in serum vitamin B12 levels (MD: −9.85 pmol/L; 95% CI: −45.64 to 25.94 pmol/L; P = 0.54, I2 = 50%) or daily intake (MD: 3.31 mcg/d; 95% CI: −4.70 to 11.32 mcg/d; P = 0.42, I2 = 90%) between plant-based Adventists and omnivore controls, although there was high heterogeneity between the studies.

Conclusion:

Adventists following a vegan or vegetarian diet did not demonstrate increased risk of vitamin B12 deficiency due to the widespread consumption of fortified foods and supplements. The findings underscore the importance of supplementation and the consumption of fortified foods for maintaining adequate B12 status among vegan or vegetarian Adventists but highlight the need for further studies to confirm these observations in diverse geographical areas.

01 Jan 2025·Journal of Gynecology Obstetrics and Human Reproduction

Vitamin B12 is correlated with insulin resistance and metabolism disorder markers in women with recurrent pregnancy loss

Article

Author: Ding, Qiuhong ; Bao, Shihua ; Li, Guohua ; Qin, Dengke ; Deng, Xujing ; Peng, Liying

OBJECTIVES:

Recurrent pregnancy loss (RPL) seriously affects women's reproductive and mental health, and the incidence has increased in recent years. Insulin resistance (IR) acts as a significant contributing factor to RPL. Studies suggest that vitamin B12, folate intake, and homocysteine are correlated with IR, but the exact nature remains controversial and requires further investigation. In this study, we aimed to assess the levels and correlations between vitamin B12-folate-homocysteine and insulin resistance in RPL patients.

STUDY DESIGN:

73 control subjects and 256 RPL patients (144 RPL patients without IR and 112 RPL patients with IR) were included in this observational retrospective cross-sectional study. The differences in vitamin B12, folate, and homocysteine levels between RPL patients with and without IR were analyzed using a Student's t-test. Pearson correlations were utilized to examine the correlation between vitamin B12-folate-homocysteine and glucose and lipid metabolism parameters. Multivariable linear regressions were used to assess the independent correlation of each factor with HOMA-IR.

RESULTS:

Compared to the control subjects, RPL patients exhibited lower vitamin B12 (p < 0.001) and folate (p < 0.001), and higher homocysteine (p = 0.001). RPL patients with IR described decreases in vitamin B12 (p = 0.003) and folate (p = 0.028), and increases in homocysteine (p = 0.033) as RPL patients without IR. Vitamin B12 in RPL patients was significantly negatively correlated with homocysteine (r = -0.348, p < 0.001), HOMA-IR (r = -0.214, p < 0.001), BMI (r = -0.160, p = 0.017), TG (r = -0.148, p = 0.039) and CHO (r = -0.149, p = 0.038) and positively correlated with folate (r = 0.217, p < 0.001). In multivariable linear regressions, after adjusting for age, strong correlations were observed between vitamin B12 (β = -0.197, p = 0.010), BMI (β = 0.466, p < 0.001), and HOMA-IR in RPL patients.

CONCLUSION:

Vitamin B12 is significantly correlated with IR in RPL patients. Circulating vitamin B12-folate-homocysteine metabolism could be a window of the pathological process of IR, obesity, and lipid metabolism disorders in RPL patients.

News (Medical) associated with Thiamine Hydrochloride

23 Sep 2024

·www.prnewswire.com

A PILL FOR ALZHEIMER'S DISEASE? CLINICAL TRIALS ON A NEW APPROACH TO TREATING ALZHEIMER'S STARTS AT 50 MEDICAL CENTERS ACROSS THE COUNTRY

NIH-funded trial will evaluate the effects of a synthetic version of vitamin B1 on cognitive function that was developed by Burke Institute for people with early Alzheimer's disease For more information about the trial and to find a study site, visit benfoteam.org WHITE PLAINS, N.Y., Sept. 23, 2024 /PRNewswire/ -- A completely different approach to stopping the progression of Alzheimer's disease pioneered by a research institute based in Westchester County, NY is now being tested nationwide. The Burke Neurological Institute (BNI), an affiliation of Weill Cornell Medicine, in partnership with the Alzheimer's Disease Cooperative Study (ADCS) at University of California San Diego and Columbia University Irving Medical Center, have launched a national clinical trial to investigate the therapeutic potential of a BNI and Weill Cornell Medicine-developed form of benfotiamine, a synthetic version of vitamin B1 (thiamine), as a treatment for mild cognitive impairment (MCI) and early Alzheimer's disease (AD). The BenfoTeam trial (The Phase 2A-2B study) taking place at 50 sites across the U.S. will evaluate the effects of benfotiamine on cognitive function and whether high doses benefit people 50-89 with mild AD and MCI. The trial is funded by the National Institute on Aging (NIA), a part of the National Institutes of Health (NIH). Benfotiamine is a synthetic drug which can increase blood thiamine up to 100 times the normal level. These levels of blood thiamine cannot be achieved by taking thiamine alone. The brain tissue in people with AD shows a thiamine deficiency, even with a sufficient supply of thiamine in a person's blood. The trial is investigating whether the delivery of thiamine via drug will increase the amount of thiamine getting to the brain and slow cognitive decline in people with early AD. Currently, 5.8 million Americans are living with AD with this number projected to rise to nearly 14 million people by 2050. "The approach of using benfotiamine in patients with mild Alzheimer's is very promising," said Rajiv Ratan, M.D., Ph.D., Executive Director at Burke Neurological Institute. "This clinical trial builds on years of hard work to address a disease that affects millions of patients " Howard Feldman, Director of the ADCS at UC San Diego said, "The launch of the BenfoTeam clinical trial represents a fresh approach with a potential treatment that is readily accessible, scientifically compelling, and cost-effective – that's a trifecta for a potential AD therapy in a Phase 2 trial – and benfotiamine has a strong safety profile." Gary E. Gibson, Ph.D., Professor of Neurosciences at BNI, has spent decades conducting studies to better understand Alzheimer's disease and how to develop new therapies to treat the disease. The BenfoTeam study builds on Gibson's scientific research conducted at Burke Neurological Institute – the only research institute in the U.S. dedicated to finding treatments to repair the brain and spinal cord. Gibson said many existing treatments or drugs in development only treat the symptoms of Alzheimer's disease such as amyloid plaques, but do not address the root cause of the disease. Benfotiamine has been shown to improve memory and diminish plaques, tangles, inflammation, and oxidative stress in animal models. In addition, unlike many of the other recently approved treatments for Alzheimer's disease, benfotiamine can be taken by mouth and does not require infusions. "In people with Alzheimer's disease, reductions in brain glucose utilization track closely with cognitive decline and we already know that thiamine deficiencies can cause dementia," said Gibson, who is also a Professor of Neuroscience in the Feil Family Brain and Mind Research Institute at Weill Cornell Medicine. "We think people with mild cognitive impairment and Alzheimer's disease may not be getting enough thiamine delivered to the brain." Jose Luchsinger, M.D., MPH, Vice-Chair for Clinical and Epidemiologic Research at Columbia University and a BenfoTeam trial co-Principal Investigator said, "While Alzheimer's disease impacts all aging populations, it is not clear that recently approved Alzheimer's therapies benefit underrepresented racial and ethnic groups. The BenfoTeam trial is designed for all patient populations.'' Participation in the trial for each patient will last 18 months (plus screening) and enrollment is planned for 406 participants. For more information about the trial and to find a study site, visit benfoteam.org or call 877-807-1290 (toll free). This research will be supported by the NIH's National Institute on Aging (R01AG076634). This content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH's National Institute on Aging. The ClinicalTrials.gov ID number for this study is: NCT06223360. About the BenfoTeam Partnership The BenfoTeam clinical research trial is funded by a grant from the National Institute on Aging (NIA) (R01AG076634). The clinical research trial is coordinated by the Alzheimer's Disease Cooperative Study (ADCS) at University of California San Diego School of Medicine and is led by principal investigators from the Burke Neurological Institute and Weill Cornell Medicine, Columbia University Irving Medical Center, and UC San Diego. SOURCE Burke Neurological Institute WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2

03 Sep 2024

·www.drugs.com

Global Study Reveals Widespread Micronutrient Deficiencies

TUESDAY, Sept. 3, 2024 -- More than 5 billion people globally do not consume enough iodine, vitamin E, and calcium, according to a study published online Aug. 29 in The Lancet Global Health . Simone Passarelli, Ph.D., from the Harvard T.H. Chan School of Public Health in Boston, and colleagues estimated micronutrient intake using a novel approach accounting for the shape of a population's nutrient intake distribution, based on dietary intake data from 31 countries. These distributions were applied to data for 185 countries for 34 age-sex groups to estimate the prevalence of nutrient intakes for 99.3 percent of the global population. The researchers found that more than 5 billion people do not consume enough iodine, vitamin E, and calcium (68, 67, and 66 percent of the global population, respectively). More than 4 billion people do not consume enough iron, riboflavin, folate, and vitamin C (65, 55, 54, and 53 percent, respectively). Within the same country and age groups, estimated inadequate intakes were higher for women with regards to iodine, vitamin B 12 , iron, and selenium, and for men with regards to magnesium, vitamin B 6 , zinc, vitamin C, vitamin A, thiamin, and niacin. "We hope this analysis sheds light on crucial nutrition challenges for locations without the necessary means to collect primary data, and improves understanding of global micronutrient inadequacy so that public health interventions can more effectively address deficiencies," the authors write. Abstract/Full Text Editorial Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

30 Aug 2024

·www.drugs.com

Billions of the World's People Deficient in Essential Micronutrients

FRIDAY, Aug. 30, 2024 -- More than half of people around the world aren’t getting enough micronutrients essential to human health, including calcium, iron and vitamins C and E, a new study says. These deficiencies are contributing to global malnutrition, as well as health problems like blindness, increased vulnerability to infections, and pregnancy complications, researchers said in The Lancet Global Health . “These results are alarming,” researcher Ty Beal , a senior technical specialist at the Global Alliance for Improved Nutrition, said in a news release. “Most people — even more than previously thought, across all regions and countries of all incomes — are not consuming enough of multiple essential micronutrients,” Beal said. “These gaps compromise health outcomes and limit human potential on a global scale.” For the study, researchers combined data from several sources to compare the nutritional intake of people in 185 countries. The team specifically assessed intake of 15 vitamins and minerals -- calcium, iodine, iron, riboflavin, folate, zinc, magnesium, selenium, thiamin, niacin, and vitamins A, B6 , B12, C and E. Researchers found widespread inadequate intake of iodine (68% of the world's population); vitamin E (67%); calcium (66%); and iron (65%). More than half of people consume inadequate levels of riboflavin, folate, and vitamins C and B6, researchers added. Intake of niacin was closest to sufficient, with 22% of people worldwide consuming too little, followed by thiamin (30%) and selenium (37%). “The public health challenge facing us is immense, but practitioners and policymakers have the opportunity to identify the most effective dietary interventions and target them to the populations most in need,” senior author Christopher Golden , associate professor of nutrition and planetary health at the Harvard T.H. Chan School of Public Health, said in a news release. Women were more likely than men to get too little iodine, vitamin B12, iron and selenium, results indicate. On the other hand, men weren't getting enough niacin, thiamin, zinc, magnesium, and vitamins A, C, and B6 compared to women, researchers said. Children and young adults 10 to 30 were most prone to low calcium intake, especially in South and East Asia and sub-Saharan Africa. Calcium intake was also low across North America, Europe and Central Asia. “Our study is a big step forward,” co-lead author Chris Free , a research professor at the University of California-Santa Barbara, said in a news release. “Not only because it is the first to estimate inadequate micronutrient intakes for 34 age-sex groups in nearly every country, but also because it makes these methods and results easily accessible to researchers and practitioners.” Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Clinical Result

100 Deals associated with Thiamine Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D02094	Thiamine Hydrochloride	A11DA01	DB00152

R&D Status

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Thiamine Deficiency	JP	Takeda Pharmaceutical Co., Ltd.	01 Dec 1952

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05157360 (CTgov)	Phase 1/2	Sepsis \| Soft Tissue Infections	10	HAT (Treatment Arm)	ligyojrlor(tikgoffzhk) = wxnfozqgnc fwxqjmiizb (bmabojufpx, fzustmhzuf - oskgtlshgo) View more	-	24 Jul 2024
				Placebo (Control Arm)	ligyojrlor(tikgoffzhk) = skcgwrmqvu fwxqjmiizb (bmabojufpx, bjlusziqvz - vejplzhjhf) View more
NCT03550794 \| NCT01070810 (Pubmed) Manual	Phase 2	Shock, Septic	158	Thiamine administration	-	Positive	06 Feb 2024
IRCT201510266917N3 (not available, Pubmed \| Int J Fertil Steril)	Phase 1	Polycystic Ovary Syndrome	64	Vitamin B1	nfjehkkgwz(mgjdurmvtj) = wgnbnrgkbm iflorligib (hricetozht ) View more	Positive	02 Feb 2024
				Thiamine (Placebo)	nfjehkkgwz(mgjdurmvtj) = hlxduyuksm iflorligib (hricetozht )
NCT03450707 (THACA, CTgov)	Phase 2	Heart Arrest	93	Thiamine 500 mg IV (Thiamine)	swwnsdntqu(lxhmqvcluq) = cqwfybqbrs crwbhbawql (qufrudaxcl, yeoplpjhpk - jilqoyivhd) View more	-	24 Aug 2023
				Placebo (Placebo)	swwnsdntqu(lxhmqvcluq) = qqqewnebbi crwbhbawql (qufrudaxcl, zikciofqju - gavalydrxd) View more
NCT03550794 (TRPSS, CTgov)	Phase 2	Kidney Diseases \| Thiamine Deficiency \| Shock, Septic	95	Thiamine Hydrochloride (Thiamine)	nolmedtviq(lxykatgcpq) = kmvwwyezbz cgjqgqmhir (khwwjolasm, sqegtzpkwc - dikxyhqdky) View more	-	27 Jun 2023
				Placebo (Placebo)	nolmedtviq(lxykatgcpq) = sfigfijhyd cgjqgqmhir (khwwjolasm, vncfgrqwmj - pfjllidoqb) View more
NCT03550794 (TRPSS, Pubmed \| Am J Respir Crit Care Med)	Phase 2	Shock, Septic	95	Thiamine	(vnmhckzbcb) = dagdbokmti hnmlczmilz (cxyibjpbpo ) View more	-	26 Jun 2023
				Placebo	(vnmhckzbcb) = szvgguiksi hnmlczmilz (cxyibjpbpo ) View more
EHA2023	Not Applicable	Vitamin B12 Deficiency Anaemia	37	Daily oral vitamin B12	fwdquyehgb(itgtjjxios) = pkihygmkcf ogkjyglead (mqzsgklwrx )	-	08 Jun 2023
				Weekly intravenous vitamin B12	fwdquyehgb(itgtjjxios) = uubhtlyqjp ogkjyglead (mqzsgklwrx )
NCT03550794 (TRPSS, ATS2023)	Phase 2	Shock, Septic	88	Thiamine (200mg) twice daily	cldowkcwbv(gbbqyavskv) = inwuyseuwr wlxasugxhn (hvjymetyve, -1.18 to 0.04) View more	Negative	21 May 2023
				Placebo	xmhagakmjm(sjhjgyusdx) = fzdzzvzvmr eoxpxafyhx (seubdchigm )
NCT03592277 (CTgov)	Phase 2	Shock, Septic	120	Vitamins C and B1 (Vitamins C and B1)	ewhlkjgfgn(zgjknjvudg) = zqnsmzxqwo dhyhhvjepl (dpgnfmejxz, qtelbjurja - eqvxhxpbbk) View more	-	28 Sep 2022
				vitamins C and B1+sodium chloride (Placebo)	ewhlkjgfgn(zgjknjvudg) = gflnxofdeq dhyhhvjepl (dpgnfmejxz, zxjercrtbg - vbykgloejq) View more
Alienor Study (ARVO2022)	Not Applicable	Age Related Macular Degeneration	963	Vitamin B5	jpolsjgrsd(kbrklrupwg) = mpzotsueyr wqhphhqdse (kolldaypob, 1.84mg)	-	01 May 2022
				Vitamin B6	jpolsjgrsd(kbrklrupwg) = dflmfuycvo wqhphhqdse (kolldaypob, 0.60mg)

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