University of Central Florida
Multiple Locations, Florida, 00000, United States
Location status: Recruiting
Location contact
Amoy Fraser, PhD, CCRP, PMP
CONTACT
Britney-Ann, BS, CTBS, CCRP
CONTACT
NCT Number: NCT07091058
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Multiple Locations, Florida, 00000, United States
Location status: Recruiting
Amoy Fraser, PhD, CCRP, PMP
CONTACT
Britney-Ann, BS, CTBS, CCRP
CONTACT
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 2 years
These data will be linked to determine if and how much contact the participant may have had with Florida waters, presence of cyanotoxin in the bio samples (blood, nasal swabs, and urine) and self-reported health issues to determine the impact of harmful algal blooms (HABs) on human health. In addition, this study will explore a potential link between self-reported COVID-19 exposure/infection and susceptibility to cyanotoxins and establish a HAB biorepository.
Time frame: 1 year
Previously enrolled cohort participants will be screened, consented and enrolled, complete a questionnaire, self- collect nasal swab and urine sample and collection of blood.
Time frame: 1 year
New participants will be screened, consented and enrolled, complete a questionnaire, self- collect nasal swab and urine sample and collection of blood.
Time frame: 2 years
Access is granted through our continued relationship with FAU and Dr. McFarland as Co-PI. The concentrations of inflammatory biomarkers will be compared between 30 participants reporting dry cough, and/or wheezy respirations and 30 who reported neither of these symptoms and for whom serum samples are stored in the biobank. The data will be analyzed using parametric statistics with adjustment for potential confounders. Statistical analyses of the relationships between environmental concentrations of HAB toxins and concentrations in human tissues will be performed initially using standard regression techniques. Multivariable modelling of the relationships between environmental concentrations, tissue concentrations, symptom frequency and biomarkers will be conducted using logistic regression and Generalized Linear Mixed Models (GLMM) as appropriate for the data form.
Time frame: 2 years
Contact information is provided by the study sponsor or research team.
Amoy Fraser, PhD, CCRP, PMP
CONTACT
Britney-Ann Wray, BS, CTBS, CCRP
CONTACT
University of Central Florida
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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