DehydrationNCT05174793
Using Urine Color as a Marker of Hydration Status
A study testing dehydration and rehydration in people with Dehydration, run by San Diego State University at 1 site in United States.
Trial summary
The purpose of this study was to determine if rapid changes in hydration status could be determined by urine color expressed in CIE color space Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Dehydration
- What is being tested?
- dehydration and rehydration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2020to 15 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-35 years of age,
- no previous heat intolerance
Who cannot join
- Pregnant women,
Trial locations and contacts
1 site in 1 country.
United States1 site
San Diego State University
San Diego, California, 92120-1805
About this study
Official title: Urine Color Expressed in CIE L*a*b* Colorspace During Rapid Changes in Hydration Status
The purpose of this study was to determine if rapid changes in hydration status could be determined by urine color expressed in CIE color space
Read the detailed description
The study will examine if urine color expressed in CIE color space can reflect hydration status. Hydration staus will be rapidly altered via exercise in the heat.
- Conditions
- Dehydration
- Being tested
- dehydration and rehydration
- Medical subject headings
- Dehydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dehydration and rehydrationOther
dehydration and rehydration
| Study group | Role | What they receive |
|---|---|---|
| dehydration to rehydration | Experimental | subjects were rehydrated following 2% dehydration Receives: Other: dehydration and rehydration |
| euhydration to dehydration | Experimental | subjects were dehydrated by 2% with exercise in the heat Receives: Other: dehydration and rehydration |
What is being measured
The primary outcome is the main question the study is designed to answer.
can urine color expressed in CIE color space reflect hydration status
urine color expressed in CIE color space
Measured: one hour dehydration and rehydration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2022
- Study start15 Mar 2020
- Primary completion15 Nov 2020
- Study completion15 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DehydrationStudies of the same condition, open and under way.
- More trials run by San Diego State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- urine color was measured during dehydration and rehydration
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael J. Buono, San Diego State University
- Investigators
- Michael Buono, Principal investigator, San Diego State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05174793
- Sponsor's protocol ID
- ENS1
- Other IDs
- 0146
- Status last verified
- Dec 2021
- First submitted
- 22 Nov 2021
- Last updated
- 3 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urine Color Expressed in CIE L*a*b* Colorspace During Rapid Changes in Hydration Status
- ClinicalTrials.gov ID
- NCT05174793
- Acronym / sponsor ID
- ENS1
- Conditions
- Dehydration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Study start
- 15 Mar 2020 (actual)
- Primary completion
- 15 Nov 2020 (actual)
- Study completion
- 15 Nov 2020 (actual)
- First posted
- 3 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to determine if rapid changes in hydration status could be determined by urine color expressed in CIE color space
Detailed description
The study will examine if urine color expressed in CIE color space can reflect hydration status. Hydration staus will be rapidly altered via exercise in the heat.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- urine color was measured during dehydration and rehydration
| Arm | Type | Receives |
|---|---|---|
| dehydration to rehydration | Experimental | Other: dehydration and rehydrationsubjects were rehydrated following 2% dehydration |
| euhydration to dehydration | Experimental | Other: dehydration and rehydrationsubjects were dehydrated by 2% with exercise in the heat |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 18-35 years of age,
- no previous heat intolerance
Key exclusion criteria (1 listed)
- Pregnant women,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dehydration and rehydrationdehydration and rehydration | Other | dehydration to rehydration, euhydration to dehydration |
Primary outcome
can urine color expressed in CIE color space reflect hydration status
Time frame: one hour dehydration and rehydration
urine color expressed in CIE color space
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2022.
- Individual participant dataSharing planned: No
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Hypernatremia Fluid Therapy in Childhood Diarrhoea
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Ondansetron to Prevent Oral Rehydration Failure in Children With Cholera
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Hydration Intervention to Decrease Side Effects Associated With GLP - 1 RA Therapy
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Hydration & Female Life Stages
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Buono principal investigator
San Diego State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dehydration and rehydration in people with Dehydration, run by San Diego State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
can urine color expressed in CIE color space reflect hydration status (time frame: one hour dehydration and rehydration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2022.