Clinical Trials

A completed clinical trial sponsored by an academic institution, the Swiss Federal Institute of Technology, evaluated the impact of dietary phytic acid on blood enrichment and human iron absorption. Because the study assessed dietary iron bioavailability across meal interventions, the formal trial phase was classified as Not Applicable. Overall, clinical research into phytic acid remains focused on nutritional and hematologic parameters governing mineral absorption.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT01521273 Completed
Enrichment of Blood
Swiss Federal Institute of Technology
 2012-03 Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Phytic acid binds and inhibits xanthine oxidase while concurrently chelating multivalent iron ions, thereby blocking enzymatic superoxide production and altering intracellular metal homeostasis. This biochemical modulation attenuates oxidative stress and inflammation, providing a therapeutic rationale for its clinical investigation in human dietary iron bioavailability and blood enrichment studies.

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.