NCT01124903

Brief Summary

The sports medicine literature provides a consensus on what threshold values constitute euhydration (normal body water) using a variety of hydration assessment markers (e.g., blood, urine). The investigators add to this literature by providing decision levels for multiple body fluids which can be used as starting points for diagnosing and treating dehydration. At present, plasma osmolality (Posm) provides the best potential measure for static dehydration assessment (spot measure), while dynamic dehydration assessment (serial monitoring) is best accomplished using change values for Posm, urine specific gravity, or body mass (weight). These findings should be considered useful for clinical, military, and sports medicine communities.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2009

Typical duration for not_applicable

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, 2009

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 14, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 17, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

April 22, 2020

Status Verified

April 1, 2020

Enrollment Period

2.1 years

First QC Date

May 14, 2010

Last Update Submit

April 20, 2020

Conditions

Keywords

dehydrationhypohydrationdiagnostic accuracybiological variationhydration assessmentbody massosmolalityplasmasalivaurine

Outcome Measures

Primary Outcomes (1)

  • Evidence of clinical dehydration

    Dehydration was carefully imposed in healthy human subjects. The diagnostic usefulness of multiple classic and novel dehydration assessment measures was made.

    24 hours

Study Arms (1)

Dehydration

EXPERIMENTAL

Multiple measures of hydration status were made when subjects were normally hydrated (euhydrated) and when dehydrated. The diagnostic usefulness of the measures was determined.

Procedure: Dehydration

Interventions

DehydrationPROCEDURE

Subjects were dehydrated by 2 - 7% of body mass over 3-5 hours using exercise-heat stress and fluid restriction.

Also known as: Hypohydration
Dehydration

Eligibility Criteria

Age18 Years - 39 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • You are a member of the U.S. Army between 18-39 years of age
  • You have passed the APFT within the previous 12 months
  • You have completed and passed a recent medical physical exam
  • You are willing to discuss with OMSO and the Principle Investigator (PI) all medications and supplements you are taking and you are willing to stop taking any supplements not approved by OMSO and the PI.

You may not qualify if:

  • You have any physical problems that would make exercise difficult
  • You have ever had a heat injury or have a history of having trouble in the heat
  • You have an allergy to sulfa drugs
  • You have been treated for dry eyes
  • You are pregnant, planning on becoming pregnant during the study, or are presently lactating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USARIEM

Natick, Massachusetts, 01760-5007, United States

Location

MeSH Terms

Conditions

Dehydration

Interventions

Organism Hydration Status

Condition Hierarchy (Ancestors)

Water-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physiological Phenomena

Study Officials

  • Samuel N Cheuvront, PhD

    United States Army Research Institute of Environmental Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: single-sample pre-post design
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2010

First Posted

May 17, 2010

Study Start

January 1, 2009

Primary Completion

February 1, 2011

Study Completion

March 1, 2011

Last Updated

April 22, 2020

Record last verified: 2020-04

Locations