NCT07220031

Effect of Activated Charcoal on Serum Osmolality, Osmolal Gap, and Enzymatic Ethylene Glycol Assay

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 8 (estimated)
• Sponsor: State University of New York - Upstate Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The goal of this observational study is to determine whether a clinically relevant dose of activated charcoal raises the serum osmolality and osmolal gap in a population of healthy volunteers. Secondarily to determine whether the same dose creates a false positive result using an enzymatic assay. 1. Does a clinically relevant dose of commercially available activated charcoal raise the osmolal gap above the baseline of a healthy volunteer? 2. Does the same dose of charcoal cause a false positive enzymatic assay for ethylene glycol? Participants will be asked to consume a dose of activated charcoal and have serial blood draws for laboratory measurements.

Detailed description

Healthy volunteers will be recruited and informed consent obtained. Exclusion criteria include acute illness or chronic condition requiring medication which would not be appropriate to discontinue due to risk for adsorption by activated charcoal. Participants will fast prior to the study period and will have baseline laboratory measures (BMP, osmolality, ethanol, ethylene glycol). They will drink a dose of 1g/kg (max 100g) of activated charcoal suspension (Actidose Aqua) in water. Serial laboratory measurements will be made at 0.5, 1, 2,4, and 6 hours (including osmolality, osmolal gap, and ethylene glycol measured by enzymatic assay). These values will be compared to the pre-treatment values to determine if there is a change in the osmolal gap or ethylene glycol result from baseline. This study is funded by the SUNY Upstate Department of Emergency Medicine and is approved by the IRB of the same institution.

Conditions

• Osmolality Disturbance
• Lab Interference

Interventions

Type	Name	Description
DRUG	Activated Charcoal	This is the only intervention

Timeline

• Start date: 2025-11-15
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2025-10-23
• Last updated: 2025-10-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study