Choline Chloride Clinical Trials

Size	Price	Qty
50mg	USD 97
1g	USD 670

Clinical Trials

Choline chloride is currently evaluated across multiple clinical trials examining its therapeutic potential in conditions such as child neurodevelopment following prenatal cannabis exposure, infant growth retardation, pregnancy, lactation, and hepatic pathologies including fatty liver disease, hepatic steatosis, and cystic fibrosis liver disease. Directed primarily by university and academic medical centers, these studies encompass Phase 1 through Phase 3 protocols along with non-phased dietary interventions. Recruitment statuses across the trial portfolio include active, not yet recruiting, completed, and terminated studies.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06910943	RECRUITING	Choline Deficiency; Liver Injury	Protara Therapeutics	2025-12-10	PHASE2; PHASE3
NCT05291104	COMPLETED	Non-alcoholic Fatty Liver Disease	Fu Jen Catholic University Hospital	2022-04-25
NCT06379971	Not yet recruiting	Child Development\|Cannabis Use	University of Colorado Denver	2024-05	Phase 1
NCT06120400	Not yet recruiting	Cardiovascular Diseases	Penn State University\|American Egg Board	2024-05	Phase 3
NCT06405360	Not yet recruiting	Infant Malnutrition\|Fetal Growth Retardation	University of Florida\|World Vision\|University of Rwanda	2024-05-02	Not Applicable
NCT06208085	Recruiting	Breastfeeding Exclusive	University of North Carolina Chapel Hill\|Avocado Nutrition Center	2024-02-08	Not Applicable
NCT03312140	COMPLETED	Cystic Fibrosis Liver Disease	University Hospital Tuebingen	2014-11-06
NCT01919424	COMPLETED	Asthma	McMaster University	2011-04
NCT01127022	COMPLETED	Pregnancy; Lactation	Cornell University	2009-01
NCT00004697	COMPLETED	Fatty Liver	University of Texas	1997-11
NCT00031135	TERMINATED	Liver Diseases	Northwestern University	2001-09	PHASE2

(data from https://clinicaltrials.gov, updated on 2026-08-24)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Choline chloride serves as an essential biological precursor for acetylcholine biosynthesis and phosphatidylcholine production, sustaining critical lipid metabolic pathways and cell membrane integrity. By facilitating one-carbon methyl group transfer and supporting hepatic very-low-density lipoprotein assembly, choline prevents intrahepatic lipid accumulation and supports neuronal signalling, directly accounting for its clinical investigation in fatty liver disease, liver injury, and neurodevelopmental conditions.

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>).