Trolox Clinical Trials

Size	Price	Qty
100mg	USD 147
250mg	USD 247

Clinical Trials

Several clinical trials sponsored by academic and medical institutions investigate parameters associated with Trolox and dietary antioxidant capacity in conditions including type 2 diabetes, female breast cancer, and metabolic syndrome. Specific protocols evaluate dietary antioxidant capacity relative to serum FGF21 levels, systemic inflammation, and lipidomic profiles. Ranging in recruitment status from completed to unknown, these trials fall under unspecified phases or those classified as Not Applicable.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05937737	Completed	Type 2 Diabetes	Hacettepe University	2020-04-20	Not Applicable
NCT04716764	Unknown status	Breast Cancer\|Female	Necmettin Erbakan University\|Hacettepe University\|Turkish Society of Medical Oncology	2020-03-03	--
NCT04053569	Unknown status	Metabolic Syndrome Protection Against	Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis	2019-10-01	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a cell-permeable, water-soluble vitamin E derivative, Trolox directly scavenges reactive oxygen species and inhibits lipid peroxidation, thereby suppressing downstream oxidative stress and cellular inflammatory cascades. By preserving intracellular redox homeostasis and protecting vital biomolecules against oxidative damage, Trolox exerts cytoprotective effects relevant to managing metabolic dysfunction and cellular damage in conditions such as type 2 diabetes, metabolic syndrome, and breast cancer.

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>).