Riboflavin Clinical Trials

Size	Price	Qty
50mg	USD 147

Clinical Trials

Multiple clinical trials evaluate riboflavin across diverse dietary and clinical applications, addressing conditions such as vitamin and mineral deficiencies, type 2 diabetes mellitus, cardiovascular diseases, obesity, bone loss, and ischemic stroke, as well as nutritional assessments in healthy cohorts. Sponsored by academic and medical institutions, including the German Federal Institute for Risk Assessment, the Swiss Federal Institute of Technology, Queen Mary University of London, and Nutricia Research, these studies feature trial phases listed as unclassified or not applicable. Recruitment statuses for these trials currently range from not yet recruiting to actively recruiting.

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	--
NCT06032234	Recruiting	Healthy	Isabelle Herter-Aeberli\|Berner Fachhochschule\|Swiss Federal Institute of Technology	2023-09-12	--
NCT05474105	Recruiting	Ischemic Stroke	Barts & The London NHS Trust\|Queen Mary University of London\|Nutricia Research	2023-07-11	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Riboflavin acts as a precursor for flavin mononucleotide and flavin adenine dinucleotide cofactors, which bind flavoproteins to catalyze essential oxidation-reduction reactions involved in cellular lipid, carbohydrate, and protein metabolism. By sustaining mitochondrial bioenergetics and redox homeostasis, riboflavin prevents cellular metabolic dysfunction and supports clinical interventions for nutritional deficiencies, cardiovascular diseases, and ischemic tissue injury.

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>).