Human Hydration Status Monitoring
1 other identifier
interventional
31
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2009
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 14, 2010
CompletedFirst Posted
Study publicly available on registry
May 17, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedApril 22, 2020
April 1, 2020
2.1 years
May 14, 2010
April 20, 2020
Conditions
Keywords
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
EXPERIMENTALMultiple measures of hydration status were made when subjects were normally hydrated (euhydrated) and when dehydrated. The diagnostic usefulness of the measures was determined.
Interventions
Subjects were dehydrated by 2 - 7% of body mass over 3-5 hours using exercise-heat stress and fluid restriction.
Eligibility Criteria
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
- United States Army Research Institute of Environmental Medicinelead
- ChromoLogic, LLCcollaborator
- Intelligent Automation, Inc.collaborator
- Gaia Medical Institutecollaborator
Study Sites (1)
USARIEM
Natick, Massachusetts, 01760-5007, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Samuel N Cheuvront, PhD
United States Army Research Institute of Environmental Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- SINGLE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- 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