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Mannitol Versus Supportive Care in Ciguatera Fish Poisoning

NCT02570971 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2015-10-07

No results posted yet for this study

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.

Conditions

  • Ciguatoxin

Interventions

DRUG

Mannitol

Sponsors & Collaborators

  • Florida Poison Control Center

    collaborator OTHER

  • University of South Florida

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2018-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02570971 on ClinicalTrials.gov