Mannitol Versus Supportive Care in Ciguatera Fish Poisoning

• Sponsor: University of South Florida (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02570971
• Collaborator: Florida Poison Control Center (Other)
• Enrollment: 200
• Arms: 2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ciguatoxin	Drug: Mannitol	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Mannitol Versus Supportive Care in Ciguatera Fish Poisoning: A Randomized Control Trial
• Study Start Date: Oct 1, 2015
• Anticipated Primary Completion Date: Jun 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control Patients will receive supportive care measures.
Experimental: Investigational Patients will receive 500mL of 20% mannitol	Drug: Mannitol

Outcome Measures

Primary Outcome Measures

1. Symptom score [24 hours]

   Covers a variety of neurological and gastrointestinal symptoms on a 0-4 score

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• History consistent with ciguatera poisoning

Exclusion Criteria:

• Minors

• pregnant patients

• those unable to give consent

• severe congestive heart failure or renal failure

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of South Florida
• Florida Poison Control Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of South Florida
• ClinicalTrials.gov Identifier: NCT02570971
• Other Study ID Numbers: CITX-2015
• First Posted: Oct 7, 2015
• Last Update Posted: Oct 7, 2015
• Last Verified: Oct 1, 2015

• Keywords provided by University of South Florida: mannitol; treatment
• Additional relevant MeSH terms: Poisoning; Ciguatera Poisoning; Mannitol

Study Results

No Results Posted as of Oct 7, 2015