(L)-Dehydroascorbic acid Clinical Trials

Size	Price	Qty
25mg	USD 149
1g	USD 1,470

Clinical Trials

Multiple clinical trials investigate (L)-dehydroascorbic acid across maternal and pediatric healthcare settings, focusing on conditions including parenteral nutrition-associated liver disease, essential fatty acid deficiency, malnutrition, pediatric acute lymphoblastic leukemia, and nutritional status in lactating mothers and infants. The research landscape encompasses a Phase IV safety evaluation sponsored by Fresenius Kabi and an observational study sponsored by the Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri. Currently, these registered studies maintain a recruitment status of not yet recruiting.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06274788	Not yet recruiting	Parenteral Nutrition Associated Liver Disease (PNALD)\|Essential Fatty Acid Deficiency\|Malnutrition\|Pediatric ALL	Fresenius Kabi	2024-05-01	Phase 4
NCT06319079	Not yet recruiting	Lactating Mothers\|Infants	Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri	2024-03	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

(L)-Dehydroascorbic acid enters cells via glucose transporters and undergoes intracellular reduction to ascorbic acid, effectively scavenging plasma-induced hydroxyl radicals in the presence of thiols to restore cellular redox homeostasis. This modulation of antioxidant capacity and free radical neutralization provides a therapeutic rationale for mitigating metabolic stress and tissue injury in conditions such as parenteral nutrition-associated liver disease and essential fatty acid deficiencies.

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>).