Evaluation of Spot Urine as a Biomarker of Fluid Intake in Real Life Conditions

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02044679

Enrollment

Registered

2014-01-24

Start date

2013-10-31

Completion date

2014-03-31

Last updated

2016-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Adults

Brief summary

Evaluate urine osmolality as a marker of fluid intake, in healthy subjects displaying a wide range of fluid intake behaviors

Interventions

OTHERWater

OTHERNo intervention

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 30 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy female and male subjects aged 20- 30 years old (both ages included). * BMI within the range 20-25 kg/m2 (both inclusive). * Height within the range 1.60-1.75 m (both inclusive) for female subjects and 1.70-1.85 m (both inclusive) for male subjects. * Monophasic contraceptive method (female subjects only) * Smoking less than 10 cigarettes/day * Fluid intake habits falling within one of three designated arms

Exclusion criteria

* Pregnant woman (as determined by a pregnancy test) or woman planning to become pregnant during the study; breast-feeding woman. * Any clinically relevant acute or chronic diseases which could interfere with the subjects' safety during the trial, or expose them to undue risk, or which could interfere with the study objectives. * Having participated in a clinical study for the renal diseases or having received any treatment related to the kidneys, cardiovascular disease or to hypertension in the last 12 months.

Design outcomes

Primary

Measure	Time frame
Osmolality	baseline

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026