Potassium Iodide Clinical Trials

Size	Price	Qty
50mg	USD 370

Clinical Trials

Several clinical trials have evaluated potassium iodide, primarily focusing on managing iodine deficiency and optimizing nutritional status during pregnancy. Encompassing a Phase 3 trial and an observational study of unspecified phase, this research was sponsored by healthcare foundations and public institutions, including the Fundació d'Investigació en Atenció Primària Jordi Gol i Gurina, University Hospital Toulouse, and the French Ministry of Health. However, these trials stopped prior to completion, with recruitment statuses recorded as withdrawn and terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01301768	Withdrawn	Dietary Intervention\|Pregnancy Jail\|Iodine Deficiency	Fundacio d''Investigacio en Atencio Primaria Jordi Gol i Gurina	2008-11	Not Applicable
NCT00379535	Terminated	Pregnancy	University Hospital Toulouse\|Ministry of Health France	2006-12	Phase 3

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Potassium iodide supplies inorganic iodide ions that accumulate in the thyroid gland via the sodium-iodide symporter, thereby inhibiting the uptake of radioactive iodine isotopes and acutely suppressing thyroid hormone organification through the Wolff-Chaikoff effect. This physiological blockage protects thyroid follicular cells from radiological and oxidative damage, providing the therapeutic rationale for managing hyperthyroidism and preventing gestational iodine deficiency.

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>).