Investigating Health Impacts of Exposure to Harmful Algal Blooms

Part of paid clinical trials in Sarasota, Florida.

Sponsor
Roskamp Institute Inc.
Study ID
NCT06883227
Status
Recruiting
Apply to this trial

Conditions

  • Florida
  • Neurologic Disorder
  • Red Tide

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Study Details

The goals of this project are to study the biological effects of environmental toxins (ET), in particular aquatic toxins such as brevetoxins (PbTx) and microcystin or their metabolites. This study is designed to examine the effects of the body from harmful algae blooms (HAB) as well as possibility of an association between exposure to the marine toxin, brevetoxin (PbTx), which is released from K. brevis during the red tide bloom, and the prevalence of neurological illnesses.

Key Dates

Start date
Oct 14, 2024
Status verified
Mar 2025
Primary completion
Oct 14, 2029
Completion
Oct 14, 2030

Study Design

Enrollment
400 participants (estimated)

Arms

  • Arm: Main Study
    All subjects will be asked to complete four in-person visits where the goal is for two visits to take place during the K. brevis bloom period and the other two visits will be when there is no K. brevis bloom ("not present" range according to the FWC K. brevis cell counts).
  • Arm: Sub-Study
    Sponsor will enroll 45 randomly selected participants from the main cohort of participants who met the inclusion/exclusion criteria and agreed to take part in the PK sub-study. The only additional exclusion criteria will be pregnancy at the time of PK study. Participants will be asked to take part in the sub-study after their first visit where there was no bloom present. Participants in the relevant locations (areas in which there is red tide bloom present) will be contacted to initiate the PK studies, and data from their prior visit (when there was no red tide bloom present) will represent their baseline data (D0).

Primary Outcome Measure

Examination of marine or similar environmental toxins short-term and long-term adverse effects on central nervous system (CNS) health, immune system, respiratory health and other biological effects induced by aquatic environmental or related toxins. [ Time Frame: 4 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Roskamp InstituteSarasotaFlorida34232
Dakota M Helgager, B.S
[email protected]
9412568010
Ayse Cemek, B.S
[email protected]
9412568019
Laila Abdullah, Ph.D (PRINCIPAL_INVESTIGATOR)

Find similar trials in Sarasota, FL

By research site
The Roskamp Institute· Sarasota, FL

Related Studies