Clinical Trials

Multiple clinical trials evaluate choline bitartrate across Phase 1 through Phase 4 protocols, sponsored primarily by academic and medical institutions under active, recruiting, and completed statuses. Research heavily focuses on maternal-fetal health and neurodevelopmental conditions—including fetal alcohol spectrum disorders, prenatal alcohol exposure, pediatric iron deficiency, and mild cognitive impairment—frequently through gestational supplementation strategies. Additionally, trials examine systemic and metabolic indications, such as TMAO-related cardiovascular risk factors, cystic fibrosis, undernutrition, and arsenic metabolite excretion.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04395196 RECRUITING
Fetal Alcohol Spectrum Disorders; Fetal Alcohol Syndrome
Wayne State University
 2023-04-13 PHASE2
NCT07699393 RECRUITING
Brain Development; Choline Nutrition
Wayne State University
 2026-07-08 PHASE2
NCT06527391 RECRUITING
Pediatric Iron Deficiency; Anemia
University of Minnesota
 2025-08-11 PHASE2; PHASE3
NCT05108974 ACTIVE_NOT_RECRUITING
Fetal Alcohol Spectrum Disorders
Jeff Wozniak
 2021-10-22 PHASE2
NCT06200883 COMPLETED
Mild Cognitive Impairment
Federico II University
 2022-09-01 PHASE4
NCT04012177 UNKNOWN
Undernutrition
Vital Pakistan Trust
 2019-07-22
NCT02735473 COMPLETED
Fetal Alcohol Spectrum Disorders
University of Minnesota
 2016-06 PHASE2
NCT03039023 COMPLETED
Cardiovascular Risk Factor
The Cleveland Clinic
 2016-09-02
NCT01149538 COMPLETED
Fetal Alcohol Spectrum Disorders; Fetal Alcohol Syndrome; Partial Fetal Alcohol Syndrome; Alcohol Related Neurodevelopmental Disorder; Prenatal Alcohol Exposure
University of Minnesota
 2010-07 PHASE1; PHASE2
NCT01749982 COMPLETED
Arsenic Metabolites Measured in Urine
Columbia University
 2012-12 PHASE4
NCT01070446 COMPLETED
Cystic Fibrosis
University of British Columbia
 2007-10

(data from https://clinicaltrials.gov, updated on 2026-07-09)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Choline bitartrate acts as an essential precursor for the biochemical synthesis of the neurotransmitter acetylcholine and structural phospholipids such as phosphatidylcholine, maintaining cellular membrane integrity and cholinergic signaling. By enhancing systemic choline availability to promote neuronal synaptic plasticity and lipid transport, it demonstrates potential clinical utility in mitigating cognitive and neurodevelopmental deficits observed in conditions like fetal alcohol spectrum disorders.

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.