Thiamine nitrate Clinical Trials

Size	Price	Qty
100mg	USD 97

Clinical Trials

Multiple clinical trials are currently evaluating thiamine interventions across various metabolic and cardiovascular conditions, including post-coronary artery bypass cognitive outcomes, pediatric left ventricular function in congenital heart disease, blood-brain barrier integrity in type 2 diabetes, and nutritional deficiencies. Sponsored primarily by academic universities and public research institutions, these studies predominantly feature Early Phase 1 and non-applicable phase designations. Current trial statuses encompass both active recruiting and not yet recruiting stages to systematically evaluate thiamine supplementation across diverse clinical cohorts.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06326996	Not yet recruiting	Coronary Heart Disease\|Coronary Artery Bypass Grafting	University of California Los Angeles	2024-05	Not Applicable
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
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	--

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Thiamine nitrate serves as an essential precursor to thiamine pyrophosphate, an obligatory coenzyme for key metabolic enzyme complexes such as pyruvate dehydrogenase and transketolase that drive cellular carbohydrate catabolism and adenosine triphosphate generation. By restoring critical mitochondrial bioenergetics and reducing metabolic stress, thiamine supplementation preserves cellular viability and supports tissue function in clinical conditions including thiamine deficiency, type 2 diabetes, and cardiovascular diseases.

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>).