Harmful Algal Blooms

ConditionRed Tide
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Central Florida

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

18 years or older

live, visit, and/ or work in the following Florida counties: Indian River, St. Lucie, Charlotte, Collier, Hendry, Hillsborough, Lee, Manatee, Martin, Monroe, Okeechobee, Palm Beach, Pasco, Pinellas, Indian River, and/or Sarasota

able to read and understand English

Disqualifiers

unable to independently consent

younger than 18 years old

prisoner

pregnant women

Trial population

The study population will include up to 400 individuals who are 18yrs of age or older, visit, live or work in specific Florida counties and who read and understand English and consent to participation.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

400 Participants
are grouped into 2 trial groups
Group A: Questionnaire A
Group B: Questionnaire B

Trial outcomes

Primary outcomes

1

To correlate self- reported symptom occurrence with recreational/occupational cyanotoxin exposure (measured in air and water environmental samples) and cyanotoxin levels in blood, nasal swab

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
2 years

Secondary outcomes

1

Continue the study of previously enrolled cohort participants prospectively to determine whether long-term effects can be attributed to exposure to microcystins and brevetoxins (Florida Red Tide).

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
2

Recruit and establish new study participants on the West Coast of Florida (coastal Lee County) to further study the health effects of exposure to Red Tide.

New 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
3

Apply novel approaches to measure biomarkers in samples included in the biobank repository and maintained in the FAU Health Clinical Research Unit using using logistic regression and Generalized Linear Mixed Models (GLMM).

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
4

Analysis of data collected during our previous studies in 2016, 2018, and 2020-2023 to explore risk factors that potentially increase the susceptibility to the respiratory impacts of harmful algal bloom toxin exposure.

Time frame
2 years

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

University of Central FloridaRecruiting00000, Multiple Locations, FloridaUnited StatesUnited States

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Central Florida

Lead sponsor

Florida Atlantic University

Collaborator

Florida Department of Health

Collaborator