Chromium picolinate Clinical Trials

Size	Price	Qty
25mg	USD 97

Clinical Trials

A clinical trial sponsored by Stony Brook University evaluated the therapeutic potential of chromium picolinate for managing insulin resistance and glucose intolerance in HIV-affected populations. This academic study reached a completed status, although a formal clinical phase was not specified in the records. Overall, the research highlights the potential application of chromium picolinate in targeting metabolic dysfunction and improving glycemic regulation.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02006914	Completed	Insulin Resistance	Stony Brook University	2005-06	--

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Chromium picolinate facilitates insulin action by enhancing the auto-phosphorylation and tyrosine kinase activity of the insulin receptor, thereby amplifying downstream intracellular signaling cascades and promoting GLUT4 translocation to the plasma membrane for enhanced cellular glucose uptake. By restoring cellular sensitivity to insulin and improving glucose clearance, this coordination complex directly counteracts impaired metabolic signaling to manage clinical conditions characterized by insulin resistance.

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>).