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Effect of Composition and Timing of Ingestion of Fluids on the Urinary Excretion of Lithogenic Substances

I

Institute of Hospitalization and Scientific Care (IRCCS)

Status

Completed

Conditions

Healthy

Treatments

Other: Water

Study type

Interventional

Funder types

Other

Identifiers

NCT03447847
43111/16

Details and patient eligibility

About

Interventional crossover study on healthy volunteers aimed at evaluating the effect of the composition and timing of ingestion of different types of water on the urinary excretion of lithogenic substances; the study will also analyze the effect of potassium citrate on urine pH and lithogenic substances

Enrollment

12 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Age >18 years

Exclusion criteria

  • Chronic malabsorption
  • Recurrent urinary tract infections
  • History of kidney stones

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

12 participants in 4 patient groups

Phase 1
Experimental group
Description:
A=oligomineral water, B=oligomineral water
Treatment:
Other: Water
Phase 2
Experimental group
Description:
A=oligomineral water, B=bicarbonate-rich water
Treatment:
Other: Water
Phase 3
Experimental group
Description:
A=bicarbonate-rich water, B=oligomineral water
Treatment:
Other: Water
Phase 4
Experimental group
Description:
A=bicarbonate-rich water, B=bicarbonate-rich water
Treatment:
Other: Water

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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