NCT01891877

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 3, 2013

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

October 20, 2014

Status Verified

October 1, 2014

Enrollment Period

3.2 years

First QC Date

June 25, 2013

Last Update Submit

October 17, 2014

Conditions

Keywords

Sickle Cell TraitFootballSicklingHeat IllnessSCT

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Current or Former Football Players

Any former or current high school or college football players who carries sickle cell trait.

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of South Florida

Tampa, Florida, 33620, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Buccal swabs will be collected from each participant.

MeSH Terms

Conditions

Sickle Cell TraitHeat Stress Disorders

Condition Hierarchy (Ancestors)

Anemia, Sickle CellAnemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesWounds and Injuries

Study Officials

  • Carroll N Flansburg, in progress

    University of South Florida

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Carroll N Flansburg, in progress

CONTACT

Lorena Madrigal, PhD Anthropology

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Coordinator

Study Record Dates

First Submitted

June 25, 2013

First Posted

July 3, 2013

Study Start

October 1, 2012

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

October 20, 2014

Record last verified: 2014-10

Locations