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Sickle Cell Trait in Football Players

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ClinicalTrials.gov Identifier: NCT01891877
Recruitment Status : Unknown
Verified October 2014 by Carroll Flansburg, University of South Florida.
Recruitment status was:  Recruiting
First Posted : July 3, 2013
Last Update Posted : October 20, 2014
Information provided by (Responsible Party):
Carroll Flansburg, University of South Florida

Brief Summary:
This study will look at the five different types of sickle cell and their relation to self-reported ill health to determine whether or not one or two of the sickle cell haplotypes are correlated with worse health outcomes. Participants can do complete the study in under half an hour in the privacy of their own home.

Condition or disease
Sickle Cell Trait

Detailed Description:
Sickle cell anemia is a disease which results from the inheritance of two hemoglobin S (Hb S) genes. Sickle-cell anemia individuals are referred to as Hb SS patients, and are known to suffer from a variety of life-threatening symptoms. Paramount in the clinical complications of sickle cell patients is the "sickle-cell crisis". If a crisis is not stopped by prompt medical attention, it may result in death. It is becoming increasingly clear that some sickle cell anemic patients have more benign clinical profiles than do others. The genetic reason for such clinical differences has been well determined: although the mutation that changes the "normal" hemoglobin gene is the same in all patients, the genetic material outside of the gene influences how the gene is expressed. This genetic material is referred to as the beta-globin haplotype. Carriers of the sickle cell gene are referred to as Hb AS individuals. Hb AS carriers usually have a normal life free of the clinical problems associated with the disease suffered by sickle cell patients. However, it is becoming increasingly clear that under strenuous situations, some Hb AS carriers do experience heat illness and other life threatening problems while others do not. The purpose of this project is to determine if there is a genetic reason for why some athlete carriers of the sickle cell trait experience heat illness, while others do not. Although the genetic reason for the different clinical outcomes of sickle cell anemic patients is now well understood (different haplotypes result in different disease courses), the possibility that the same haplotypes might be the reason why some sickle cell carriers have worse clinical profiles has never been explored. In this project we will work with a sickle-cell trait registry of athletes, and we will test the haplotypes of Hb AS athletes who have and who have not had heat illness. Our study is the first to attempt to clarify if there is a genetic reason for this occurrence. Total participation time for the study is thirty minutes or less. Information provided by the participant will be analyzed within one year of participation. Deidentified results will be kept for five years, per the University of South Florida's Institutional Review Board protocol, and will be available upon request to the principal investigator. Participants can do complete the study in under half an hour in the privacy of their own home.

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Is Sickle Cell Trait as Benign as is Usually Assumed?
Study Start Date : October 2012
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Current or Former Football Players
Any former or current high school or college football players who carries sickle cell trait.

Primary Outcome Measures :
  1. Poor health outcomes [ Time Frame: 30 minutes or less to complete survey and buccal swab ]
    Any ill health events, such as excessive dehydration, muscle cramping, fatigue, shortness of breath, sickling crises, that can be linked to a sickling event.

Biospecimen Retention:   Samples With DNA
Buccal swabs will be collected from each participant.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The study population consists of adult males who currently or formerly played high school or college football and know that they carry sickle cell trait.

Inclusion Criteria:

  • over the age of 18
  • male
  • has previously played or currently plays high school or college football
  • carries sickle cell trait

Exclusion Criteria:

  • under the age of 18
  • female
  • does not carry sickle cell trait
  • has not played or does not play high school or college football

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01891877

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Contact: Carroll N Flansburg, in progress 8025851054 cflansbu@mail.usf.edu
Contact: Lorena Madrigal, PhD Anthropology 8139742138 madrigal@usf.edu

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United States, Florida
University of South Florida Recruiting
Tampa, Florida, United States, 33620
Principal Investigator: Carroll N Flansburg, in progress         
Sponsors and Collaborators
University of South Florida
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Principal Investigator: Carroll N Flansburg, in progress University of South Florida
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Responsible Party: Carroll Flansburg, Research Coordinator, University of South Florida
ClinicalTrials.gov Identifier: NCT01891877    
Other Study ID Numbers: SCT in Football
NCAA ( Other Identifier: National Collegiate Athletic Association )
First Posted: July 3, 2013    Key Record Dates
Last Update Posted: October 20, 2014
Last Verified: October 2014
Keywords provided by Carroll Flansburg, University of South Florida:
Sickle Cell Trait
Heat Illness
Additional relevant MeSH terms:
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Sickle Cell Trait
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Hematologic Diseases
Genetic Diseases, Inborn