Clinical Trials

A clinical trial sponsored by Xinhua Hospital affiliated with Shanghai Jiao Tong University School of Medicine investigates phosphocholine in relation to clinical and metabolic outcomes by evaluating genomic and metabolomic variations linked to choline profiling. The research focuses on risk factors associated with preterm birth and clinical responses in pediatric patients receiving total parenteral nutrition. Currently listed with an unknown recruitment status, the study does not specify a formal trial phase designation.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT02841813 Unknown status
Genomic and Metabolomic Variations|Preterm Birth|Total Parenteral Nutrition
Xinhua Hospital Shanghai Jiao Tong University School of Medicine
 2016-03 --

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

Check the Phosphocholine chloride calcium salt tetrahydrate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Phosphocholine serves as a key endogenous intermediate in the CDP-choline metabolic pathway, functioning as a primary precursor for phosphatidylcholine biosynthesis to maintain cell membrane structural integrity and lipid signaling cascades. By regulating phospholipid turn-over and cellular lipid homeostasis, this metabolite modulates systemic transport mechanisms relevant to metabolomic variations, preterm birth risk, and metabolic support in infants undergoing total parenteral nutrition.

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>).

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Note: Technical data last updated: Sep 1, 2026.