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Active, not recruitingNCT07220031Updated Jul 31, 2026

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

An observational study in Osmolality Disturbance and Lab Interference, sponsored by State University of New York - Upstate Medical University. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-31.

Sponsored by State University of New York - Upstate Medical University · Observational

From the registry’s dates

  • Primary completion was expected by Jul 2026, 3 months ago, but the record still lists the study as active, not recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
8
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Osmolality Disturbance
  • Lab Interference

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Keywords

  • activated charcoal
  • serum osmolality
  • osmolal gap
  • ethylene glycol
  • glycerol dehydrogenase
03

In context

Anthrax

75 studies on the registry are indexed under Anthrax; 12 are open to participants now.

This study's planned enrollment of 8 is below the median of 99 across 16 observational studies indexed under Anthrax.

Browse Anthrax studies →

Lead sponsor

State University of New York - Upstate Medical University is the lead sponsor of 157 studies on the registry; 18 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 4 (36%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Healthy volunteers

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Healthy adults

Exclusion criteria

Exclusion Criteria:

  • Any medical comorbidities
  • Recent illness
  • Pregnancy
  • Prisoners
  • Non-English speaking
  • Weight > 100 kg
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
8 participants (estimated)
Patient registry
No

Groups and cohorts

  • Charcoal

    Healthy volunteers to consume activated charcoal

    Drug: Activated Charcoal

Interventions

06

What researchers measure

Primary outcomes

  1. Osmol Gap Change

    Delta serum osmolality and osmolal gap at time points 0.5, 1, 2, 4, and 6 hours after Activated charcoal given

    Time frame: 6 hours

Secondary outcomes

  1. Ethylene Glycol

    Numeric result of ethylene glycol testing (measured by glycerol dehydrogenase assay) before and after charcoal.

    Time frame: 6 hours

07

Study locations

1 site
  • Upstate Medical University Clinical Research Unit
    Syracuse, New York 13210, United States
08

References and documents

Publications

  • Robson AF, Lawson AJ, Lewis L, Jones A, George S. Validation of a rapid, automated method for the measurement of ethylene glycol in human plasma. Ann Clin Biochem. 2017 Jul;54(4):481-489. doi: 10.1177/0004563216667752. Epub 2016 Aug 17. PubMed 27538769 ↗
  • Rooney SL, Ehlers A, Morris C, Drees D, Davis SR, Kulhavy J, Krasowski MD. Use of a Rapid Ethylene Glycol Assay: a 4-Year Retrospective Study at an Academic Medical Center. J Med Toxicol. 2016 Jun;12(2):172-9. doi: 10.1007/s13181-015-0516-6. PubMed 26553280 ↗
  • Huntbach W, Moss M. Rapid availability of ethylene glycol test results with enzymatic assay. Clin Toxicol (Phila). 2024 Aug;62(8):536-538. doi: 10.1080/15563650.2024.2377281. Epub 2024 Jul 15. PubMed 39007755 ↗
  • Coulson L, Surla A, Tran V, Hoggett K. Severe glycerol intoxication mimicking toxic alcohol ingestion following large volume consumption of vanilla essence. Clin Toxicol (Phila). 2022 Nov;60(11):1248-1250. doi: 10.1080/15563650.2022.2114911. Epub 2022 Aug 31. PubMed 36043532 ↗
  • Burkitt JM, Haskins SC, Aldrich J, Jandrey KE, Rezende ML, Boyle JE. Effects of oral administration of a commercial activated charcoal suspension on serum osmolality and lactate concentration in the dog. J Vet Intern Med. 2005 Sep-Oct;19(5):683-6. doi: 10.1892/0891-6640(2005)19[683:eooaoa]2.0.co;2. PubMed 16231712 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07220031
Responsible party
Sponsor
First posted
Oct 23, 2025
Start date
Nov 15, 2025
Primary completion
Jul 31, 2026 (estimated)
Completion
Jul 31, 2026 (estimated)
Last update
Jul 31, 2026

Study contacts

Vincent Calleo, MD
principal investigator · Upstate Medical University

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.

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