Thiamine monochloride Clinical Trials

Size	Price	Qty
25mg	USD 97

Clinical Trials

Multiple clinical trials evaluate the therapeutic and nutritional applications of thiamine monochloride across clinical conditions including type 2 diabetes mellitus, cardiovascular disease, morbid obesity, ischemic stroke, and nutritional deficiencies. Sponsored by academic and public research institutions, these studies predominantly involve non-applicable or unspecified phases, with recruitment statuses spanning completed, active recruiting, and not yet recruiting stages. Collectively, these efforts focus on evaluating nutrient bioavailability, dietary intake, and risk modulation in metabolic and cardiovascular contexts.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
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	--
NCT06057597	Recruiting	Obesity\|Morbid	Assistance Publique - Hôpitaux de Paris	2023-11-13	Not Applicable
NCT05474105	Recruiting	Ischemic Stroke	Barts & The London NHS Trust\|Queen Mary University of London\|Nutricia Research	2023-07-11	Not Applicable
NCT05742516	Recruiting	Exogenous Carbohydrate Oxidation	University of Bath\|Clasado Biosciences	2023-04-23	Not Applicable
NCT05610137	Completed	Dietary Intake	Vanessa Corrales Agudelo\|Vidarium Nutrition Health and Wellness Research Center	2022-10-18	--
NCT05382533	Completed	Decreased Cardovascular Risk\|Decreased Risk of Diabetes Mellitus Type II	University of Jena	2022-05-30	Not Applicable

(data from https://clinicaltrials.gov, updated on 2024-05-22)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Thiamine monochloride acts as a crucial coenzyme precursor in essential metabolic pathways, facilitating carbohydrate metabolism and mitochondrial ATP production. By maintaining cellular energy homeostasis and enzymatic function, this vitamin supports physiological neuronal activity and systemic metabolic stability, which is directly relevant to clinical trials investigating nutrient deficiency, metabolic dysfunction, and cardiovascular risk reduction.

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>).