choline
CHOLINE is a basic constituent of lecithin that is found in many plants and animal organs. Choline was officially recognized as an essential nutrient by the Institute of Medicine in 1998.1 Its role in the body is complex. It is needed for neurotransmitter synthesis (acetylcholine), cell-membrane signaling (phospholipids), lipid transport (lipoproteins), and methyl-group metabolism (homocysteine reduction). It is the major dietary source of methyl groups via the synthesis of S-adenosylmethionine (AdoMet). At least 50 AdoMet-dependent reactions have been identified in mammals, and it is likely that the number is much higher. Choline is required to make the phospholipids phosphatidylcholine, lysophosphatidylcholine, choline plasmalogen, and sphingomyelin—essential components for all membranes. It plays important roles in brain and memory development in the fetus and appears to decrease the risk of the development of neural tube defects. The importance of choline in the diet extends into adulthood and old age. In a study of healthy adult subjects deprived of dietary choline, 77% of the men and 80% of the postmenopausal women developed signs of subclinical organ dysfunction (fatty liver or muscle damage). Less than half of premenopausal women developed such signs. Ten percent of the subjects studied developed fatty liver, muscle damage, or both when they consumed the Adequate Intake (AI) of choline. The damage was reversed when they consumed a high-choline diet. Plasma choline concentration has been found to vary in response to diet, decreasing approximately 30 percent in humans fed a choline-deficient diet for 3 weeks. Based on estimated dietary intakes and studies reporting liver damage with lower choline intakes, the Institute of Medicine, Food and Nutrition Board set the AI for choline at 425 milligrams/per day for women aged 19 and older, and 550 milligrams/per day for men aged 19 and older. — NCATS
Clinical trial activity
27 trials · 34 clinical orgs · 0 marketing orgs
Earliest trial started May 31, 2013 (NCT01911299)
Timeline
Indications
Approved for
Studied for
- Alcoholism · Phase 2
- Alzheimer Disease · Phase 1
- Anemia · Phase 2/Phase 3
- Autistic Disorder · Phase 4
- Cannabis · Phase 1
- Child Development · Phase 1
- Choline Deficiency · Phase 2/Phase 3
- Cognitive Dysfunction · Phase 4
- Fatty Liver · Phase 4
- Fetal Alcohol Spectrum Disorders · Phase 2/Phase 3
- Health · Phase 1
- Hodgkin Disease · Phase 1
- Iron Deficiencies · Phase 2/Phase 3
- Leukemia, Hairy Cell · Phase 1
- Liver Diseases · Phase 2/Phase 3
- Lymphoma, Non-Hodgkin · Phase 1
- Multiple Myeloma · Phase 1
- Postoperative Pain · Phase 4
- Triple Negative Breast Neoplasms · Phase 2
Mechanism of action
- cholineSupplementation
choline supplementation
Chemistry & pharmacology
SMILES
C[N+](C)(C)CCO- Mol. weight
- 104.1708 g/mol
Oral
No
Parenteral
No
Topical
No
Sources
- WikipediaCholine chloride ↗
- NCATSN91BDP6H0X ↗
- WikipediaCholine ↗
Also known as
- trimethylethanolamine
- trimethylethanolamine
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06910943 | Phase 2/Phase 3 (Phase 3) | Nov 30, 2025 | Protara Therapeutics |
| NCT06527391 | Phase 2/Phase 3 (Phase 3) | Dec 2, 2024 | University of Minnesota |
| NCT06379971 | Phase 1 | Oct 24, 2024 | University of Colorado, University of Colorado, Denver |
| NCT06924541 | N/A | Sep 1, 2024 | University of Vermont |
| NCT05859126 | N/A | Jul 31, 2023 | Cornell University |
| NCT05880849 | Phase 1 | Jun 26, 2023 | Balchem Corporation, Massachusetts Institute of Technology, University of Texas at Houston |
| NCT06531720 | N/A | Jan 1, 2023 | Silesian University of Medicine |
| NCT06200883 | Phase 4 | Sep 1, 2022 | University of Naples Frederico II |
| NCT07264257 | N/A | Jun 15, 2022 | Balchem Corporation, University of Vermont |
| NCT05291104 | N/A | Apr 1, 2022 | Fu Jen Catholic University |
| NCT05108974 | Phase 2 | Oct 22, 2021 | National Institute on Alcohol Abuse and Alcoholism (NIAAA), University of Minnesota |
| NCT05076682 | Phase 2 | Oct 15, 2021 | Fudan University |
| NCT05052515 | N/A | Sep 30, 2021 | University of Athens |
| NCT04395196 | Phase 2/Phase 3 (Phase 3) | Feb 1, 2021 | Columbia University, University of Cape Town, Wayne State University |
| NCT04764162 | N/A | Dec 15, 2020 | Virginia Polytechnic Institute and State University |
| NCT04640779 | Phase 1 | Dec 15, 2020 | Mayo Clinic, National Cancer Institute (NCI) |
| NCT04987099 | N/A | Dec 13, 2020 | Cornell University |
| NCT04302168 | N/A | Apr 1, 2020 | Maimonides Medical Center |
| NCT04147624 | Phase 2 | Dec 1, 2019 | American Academy of Neurology, University of Miami |
| NCT04012177 | N/A | Jul 22, 2019 | Aga Khan University, Vital Pakistan Trust |