Mannitol Versus Supportive Care in Ciguatera Fish Poisoning

Mannitol Versus Supportive Care in Ciguatera Fish Poisoning: A Randomized Control Trial

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02570971

Enrollment

200

Registered

2015-10-07

Start date

2015-10-31

Completion date

Unknown

Last updated

2015-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ciguatoxin

Keywords

mannitol, treatment

Brief summary

Ciguatera poisoning, caused by the ingestion of ciguatoxin-containing fish, is a global public health concern. In the US, the vast majority of ciguatera poisonings occur in Florida, followed by Hawaii and California. Equipoise exists in the medical literature regarding the effectiveness of mannitol therapy in treatment of ciguatera poisoning. While there are many case reports attesting to its utility, the only randomized control trial (RCT) comparing mannitol therapy with supportive care failed to show any significant benefit from mannitol treatment for a variety of clinical outcomes. Investigators therefore propose a second, larger RCT to test this question.

Interventions

DRUGMannitol

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

Healthy volunteers

Inclusion criteria

* History consistent with ciguatera poisoning

Exclusion criteria

* Minors * pregnant patients * those unable to give consent * severe congestive heart failure or renal failure

Design outcomes

Primary

Measure	Time frame	Description
Symptom score	24 hours	Covers a variety of neurological and gastrointestinal symptoms on a 0-4 score

Contacts

Primary ContactMichael Butterfield, MD MS MPH

mbutterfield@health.usf.edu

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026