Choline chloride

Table of contents

• What is choline chloride?
• How does choline chloride work?
• Which conditions is it used or studied for?
• How is choline chloride given?
• What do the clinical trials show?
• What side effects are known?

What is choline chloride?

Choline chloride is a chemical form of choline, an essential nutrient that the body needs for several important functions. In the trial described here, it is an investigational substance being studied as an intravenous source of choline for people with intestinal failure who rely on long-term parenteral support (feeding given directly into the vein).^[1] The substance is listed in the NHS dm+d browser as an ingredient, where it appears in a product called Ketovite liquid sugar free.^[2] A related form of choline, choline alfoscerate, is authorised as a medicine in Italy and Poland under names such as Delecit and Gliatilin.^[3]

How does choline chloride work?

Choline is a nutrient that the body uses to build cell membranes, support liver function, and produce the neurotransmitter acetylcholine, which is involved in memory and muscle control. In people with intestinal failure who receive long-term intravenous feeding, blood levels of choline can become low because standard parenteral nutrition may not provide enough choline. The trial is testing whether giving choline chloride directly into the vein can raise plasma free choline concentrations to a target level of at least 9.5 nmol/mL.^[1]

Which conditions is it used or studied for?

• Intestinal failure — a condition in which the intestines cannot absorb enough nutrients and fluids, so the person needs long-term intravenous feeding (parenteral support). The authorised Phase 4 trial is studying choline chloride in adolescent and adult patients with this condition.^[1]

How is choline chloride given?

In the clinical trial, choline chloride is given as an injection for intravenous use. The dose being studied is 4 grams, administered directly into the vein.^[1] The NHS dm+d browser lists choline chloride as an ingredient in an oral liquid product (Ketovite liquid sugar free), which shows that the substance can also be formulated for oral use in other contexts.^[2] The related substance choline alfoscerate is available in Italy and Poland as capsules, oral solutions, and injectable solutions.^[3]

What do the clinical trials show?

One Phase 4 clinical trial (NCT06910943) is authorised for choline chloride. The trial is interventional and has a planned enrollment of 144 adolescent and adult participants with intestinal failure who are receiving long-term parenteral support.^[1]

The trial has three parts. In the dose-selection part, researchers measure pharmacokinetic (PK) parameters — how the drug moves through the body — and assess safety. In the double-blind part, participants are randomly assigned to receive either Choline Chloride for Injection or a matching placebo, and the researchers compare the change in peak plasma free choline concentrations at Week 8 between the two groups. In the open-label part, all participants receive choline chloride, and the researchers measure the percentage of participants who reach and maintain plasma free choline concentrations of at least 9.5 nmol/mL at Week 8 and Week 64.^[1]

Safety is measured in all three parts by recording the incidence and severity of treatment-emergent adverse events (TEAEs) — side effects that appear or worsen during treatment — and treatment-emergent serious adverse events (TESAEs).^[1]

What side effects are known?

The supplementary sources provided do not describe specific side effects for choline chloride. The clinical trial is actively collecting safety information by recording the incidence and severity of treatment-emergent adverse events and serious adverse events in all three parts of the study.^[1]