NCT00601029

Brief Summary

The purpose of this study is to:

  1. 1.develop a normative database for serum creatine kinase (CK) responses to basic military training (BMT);
  2. 2.determine the incidence of exertional rhabdomyolysis (ER) among a large cohort of recruits undergoing BMT;
  3. 3.assess the impact of climate on the incidence of ER during BMT;
  4. 4.determine the incidence of candidate genes that may be associated with an increased risk of ER.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
499

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2008

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

January 14, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 25, 2008

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

April 20, 2012

Status Verified

April 1, 2012

Enrollment Period

1.7 years

First QC Date

January 14, 2008

Last Update Submit

April 18, 2012

Conditions

Exertional Rhabdomyolysis

Keywords

Exertional Rhabdomyolysis

Outcome Measures

Primary Outcomes (1)

  • Exertional Rhabdomyolysis

    Day 0, 3, 7 and 14 of basic training

Study Arms (2)

1

Winter Phase - Observational

2

Summer Phase - Observational

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Military Basic Trainee at Ft. Benning undergoing Infantry Basic Training Male \> 18 years old

You may qualify if:

  • Enrolled in Basic Training at Ft. Benning
  • Between the ages of 18 and 45
  • Active Duty
  • Able to speak and read English
  • Held in inprocessing seven days or less

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Martin Army Community Hospital

Fort Benning, Georgia, 31905, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum and stored blood

Study Officials

  • Rodney S Gonzalez, MD

    Martin Army Community Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Warrior Care

Study Record Dates

First Submitted

January 14, 2008

First Posted

January 25, 2008

Study Start

January 1, 2008

Primary Completion

September 1, 2009

Study Completion

September 1, 2010

Last Updated

April 20, 2012

Record last verified: 2012-04

Locations

US(1)