NCT01981902

Brief Summary

Dehydration can result from exposure to harsh environments including hot and dry desert climates. Soldiers and non-military workers are frequently required to work in hot, dry conditions, and dehydration can be productivity limiting and life threatening if unrecognized.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

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

August 1, 2013

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

August 13, 2013

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 13, 2013

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

November 1, 2022

Status Verified

October 1, 2022

Enrollment Period

5 years

First QC Date

August 13, 2013

Last Update Submit

October 28, 2022

Conditions

Keywords

Dehydration

Outcome Measures

Primary Outcomes (1)

  • Hydration

    Marathon Trainees

    up to 4 weeks

Study Arms (1)

Dehydration

Non-Invasive Optical Spectroscopic monitoring method for dehydration

Device: Non-Invasive Optical Spectroscopic

Interventions

Non-Invasive Optical Spectroscopic

Dehydration

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Study population are the volunteers who are training for a marathon individually or under the guidance of the Leukemia Society Team in Training, the American Heart Association, or similar groups. These organizations run programs that include providing group-training situations for individuals interested in preparing for a marathon while participating in fund raising efforts.

You may qualify if:

  • male female ages of 18 and 60
  • training for a marathon

You may not qualify if:

  • Poorly controlled diabetes mellitus
  • Diabetes insipidus (excessive urination of water) as diagnosed by your physician
  • disorder of the intestine
  • Irritable bowel syndrome with excessive diarrhea, as diagnosed by a physician
  • Congestive heart failure and subsequent use of a diuretic "water pill" to remove excess water from the body
  • Have poor kidney function
  • Have been diagnosed with hyperthyroidism/hypothyroidism by your physician

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beckman Laser Institute University of California Irvine

Irvine, California, 92612, United States

Location

MeSH Terms

Conditions

Dehydration

Condition Hierarchy (Ancestors)

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

Study Officials

  • Matthew Brenner, MD

    Beckman Laser Institute

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Matthew Brenner, M.D.,Department of Pulmonary and Critical Care Medicine

Study Record Dates

First Submitted

August 13, 2013

First Posted

November 13, 2013

Study Start

August 1, 2013

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

November 1, 2022

Record last verified: 2022-10

Locations