Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 10:01 PM
Study NCT ID:
NCT07091058
Status:
RECRUITING
Last Update Posted:
2025-07-29
First Post:
2025-07-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Harmful Algal Blooms
Sponsor:
University of Central Florida
Organization:
Study Overview
Official Title:
Health Outcomes Associated With Algal Blooms of Cyanobacteria and Red Tide in in Florida: Long-Term Health Impacts of Harmful Algal Bloom Exposure, Phase 2
Status:
RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to compare the frequency of symptoms, exposure and health impacts in persons living in areas where they are exposed to bloom and non-bloom periods of cyanobacteria and red tide in Florida.
Detailed Description:
Florida has experienced multiple harmful algal blooms during the past several years of two predominant types of Florida red tides occur in the Gulf of Mexico and are due to proliferation of the dinoflagellate Karenia brevis which produces a suite of highly irritative compounds known as brevetoxins. Human illness is primarily due to inhalation of aerosols, which results in a well-characterized syndrome of respiratory tract symptoms due to the irritative effects of brevetoxin.
The proposed study will utilize a case-control approach to compare symptom frequency during bloom and non-bloom period sampling to compare exposures and health impacts. In addition, for the exposed group, comparison of bloom cell density will be examined. As in our previous study, sampling locations will include Fort Myers region, Stuart, and communities around Lake Okeechobee (for example Clewiston and Indiantown). Continuing data collection sites will include: The Volunteers in Medicine Clinic (VIM) in Stuart, Public Health Department in Clewiston, Florida Public Works Department in Cape Coral, and FAU Clinical Research Unit in Boca Raton, FL.
The proposed study will utilize a case-control approach to compare symptom frequency during bloom and non-bloom period sampling to compare exposures and health impacts. In addition, for the exposed group, comparison of bloom cell density will be examined. As in our previous study, sampling locations will include Fort Myers region, Stuart, and communities around Lake Okeechobee (for example Clewiston and Indiantown). Continuing data collection sites will include: The Volunteers in Medicine Clinic (VIM) in Stuart, Public Health Department in Clewiston, Florida Public Works Department in Cape Coral, and FAU Clinical Research Unit in Boca Raton, FL.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: