NCT07220031

Brief 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. 1.Does a clinically relevant dose of commercially available activated charcoal raise the osmolal gap above the baseline of a healthy volunteer?
  2. 2.Does the same dose of charcoal cause a false positive enzymatic assay for ethylene glycol?

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 21, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 23, 2025

Completed
23 days until next milestone

Study Start

First participant enrolled

November 15, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

October 23, 2025

Status Verified

October 1, 2025

Enrollment Period

6 months

First QC Date

October 21, 2025

Last Update Submit

October 21, 2025

Conditions

Osmolality DisturbanceLab Interference

Keywords

activated charcoalserum osmolalityosmolal gapethylene glycolglycerol dehydrogenase

Outcome Measures

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

    6 hours

Secondary Outcomes (1)

  • Ethylene Glycol

    6 hours

Study Arms (1)

Charcoal

Healthy volunteers to consume activated charcoal

Drug: Activated Charcoal

Interventions

Activated CharcoalDRUG

This is the only intervention

Charcoal

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy volunteers

You may qualify if:

  • Healthy adults

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Upstate Medical University Clinical Research Unit

Syracuse, New York, 13210, United States

Location

Related Publications (5)

  • 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.

    PMID: 27538769BACKGROUND

  • 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.

    PMID: 26553280BACKGROUND

  • 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.

    PMID: 39007755BACKGROUND

  • 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.

    PMID: 36043532BACKGROUND

  • 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.

    PMID: 16231712BACKGROUND

MeSH Terms

Conditions

Anthrax

Interventions

Charcoal

Condition Hierarchy (Ancestors)

Bacillaceae InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

CarbonElementsInorganic Chemicals

Study Officials

  • Vincent Calleo, MD

    Upstate Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Vincent Calleo, MD

CONTACT

3154646224calleov@upstate.edu

Matthew Kolbeck, MD

CONTACT

315-464-6224kolbeckm@upstate.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2025

First Posted

October 23, 2025

Study Start

November 15, 2025

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

October 23, 2025

Record last verified: 2025-10

Locations

US(1)