Sickle Cell Trait in Football Players

Sickle Cell Trait Clinical Trial

Official title:

Is Sickle Cell Trait as Benign as is Usually Assumed?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01891877
• Other study ID #: SCT in Football
• Secondary ID: NCAA
• Status: Recruiting
• Phase: N/A
• First received: June 25, 2013
• Last updated: October 17, 2014
• Start date: October 2012
• Est. completion date: December 2015

Study information

• Verified date: October 2014
• Source: University of South Florida
• Contact: Carroll N Flansburg, in progress
• Phone: 8025851054
• Email: cflansbu[@]mail.usf.edu
• Is FDA regulated: No
• Health authority: United States: University of South Florida Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Sickle Cell Trait

Locations

Country	Name	City	State
United States	University of South Florida	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of South Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Poor health outcomes	Any ill health events, such as excessive dehydration, muscle cramping, fatigue, shortness of breath, sickling crises, that can be linked to a sickling event.	30 minutes or less to complete survey and buccal swab	No

External Links

•   USF Sickle Cell Initiative - information regarding study at bottom of page