Variation in Urine Electrolytes, pH and Specific Gravity Throughout the Day
| Status: | Recruiting |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/11/2019 |
| Start Date: | August 28, 2018 |
| End Date: | December 2019 |
| Contact: | Brenda Romeo, CCRC |
| Email: | amcurologyresearch@amc.edu |
| Phone: | 518-262-8579 |
Variation in Urine Electrolytes, pH and Specific Gravity Throughout the Day and the Effect of Increased Fluid Intake on Intra-Day Urine Composition
This study is a prospective study looking at healthy adults who will have urine collected at
4 set times throughout the course of the day. On Day 2, 3, and 4 subjects will drink a bottle
of water containing True lemon and on days 2 and 3 double the amount of fluid intake from Day
1. On day 4 the subject will collect urine samples at 4 set times throughout the day. The pH
of all of the urine samples will be checked with a urine dipstick and the samples will be
sent to Litholink Lab for electrolyte composition analysis.
4 set times throughout the course of the day. On Day 2, 3, and 4 subjects will drink a bottle
of water containing True lemon and on days 2 and 3 double the amount of fluid intake from Day
1. On day 4 the subject will collect urine samples at 4 set times throughout the day. The pH
of all of the urine samples will be checked with a urine dipstick and the samples will be
sent to Litholink Lab for electrolyte composition analysis.
20 subjects will be recruited and consented in the Urology Clinic office. Subjects will
complete a questionnaire asking about weight, height, history of kidney stones, whether they
are on any diuretics, medications that alter urine chemistries, or special diets. BMI will be
calculated. Day 1 will begin at 5p.m. on the day before first morning void is collected. The
subjects will collect a spot urine sample on the first void at home, then at 9-10AM, 1-2 PM
and 4-5PM. They will be provided 4 sterile urine cups labeled for the different timed
collection marked at the 20-30 ml line to indicate how much urine should be collected.
Subjects will be instructed to refrigerate their first voids.The 2nd, 3rd and 4th void
samples will be collected in the office during the designated times, and given to study
personnel. The subjects will record the time of each void, the time given to the study
representative, the times they eat, and their approximate fluid intake on the provided
diaries. Subjects will be asked not to void outside of the timed collections. If they do void
outside of these times, they will be asked to record the extra times that they void.
On Day 2, 3, and 4 the subject will drink a bottle of water with True Lemon after 5pm. On
days 3 and 4 the subjects will double their fluid intake using Day 1 as a guide. On Day 4 the
subjects will collect 4 urine samples as previously described for Day1. They will be
instructed to mix 1 packet of True lemon in one 16.9oz (500 mL) bottle of Poland Spring. All
True Lemon packets (True Citrus, 11501 Pocomoke Court Suite D, Baltimore, MD 21220). and
Poland Spring (Nestle Waters North America) bottles will be provided to subjects by the
research study team.
UA dipsticks will be used in office to evaluate for pH and specific gravity. Samples will
also be sent to lab for evaluation of chemical composition of creatinine, citrate, and
calcium. Electrolytes will be indexed against creatinine to evaluate their concentrations
without having a 24-hour void volume amount A sample of citrate-Poland Spring will be sent to
Litholink for analysis of Calcium and Citrate for reference.
complete a questionnaire asking about weight, height, history of kidney stones, whether they
are on any diuretics, medications that alter urine chemistries, or special diets. BMI will be
calculated. Day 1 will begin at 5p.m. on the day before first morning void is collected. The
subjects will collect a spot urine sample on the first void at home, then at 9-10AM, 1-2 PM
and 4-5PM. They will be provided 4 sterile urine cups labeled for the different timed
collection marked at the 20-30 ml line to indicate how much urine should be collected.
Subjects will be instructed to refrigerate their first voids.The 2nd, 3rd and 4th void
samples will be collected in the office during the designated times, and given to study
personnel. The subjects will record the time of each void, the time given to the study
representative, the times they eat, and their approximate fluid intake on the provided
diaries. Subjects will be asked not to void outside of the timed collections. If they do void
outside of these times, they will be asked to record the extra times that they void.
On Day 2, 3, and 4 the subject will drink a bottle of water with True Lemon after 5pm. On
days 3 and 4 the subjects will double their fluid intake using Day 1 as a guide. On Day 4 the
subjects will collect 4 urine samples as previously described for Day1. They will be
instructed to mix 1 packet of True lemon in one 16.9oz (500 mL) bottle of Poland Spring. All
True Lemon packets (True Citrus, 11501 Pocomoke Court Suite D, Baltimore, MD 21220). and
Poland Spring (Nestle Waters North America) bottles will be provided to subjects by the
research study team.
UA dipsticks will be used in office to evaluate for pH and specific gravity. Samples will
also be sent to lab for evaluation of chemical composition of creatinine, citrate, and
calcium. Electrolytes will be indexed against creatinine to evaluate their concentrations
without having a 24-hour void volume amount A sample of citrate-Poland Spring will be sent to
Litholink for analysis of Calcium and Citrate for reference.
Inclusion Criteria:
- Healthy adult subjects
Exclusion Criteria:
- Subjects taking diuretics
- Subjects who have known kidney disease
- Subjects with history of known nephrolithiasis
We found this trial at
1
site
47 New Scotland Ave
Albany, New York 12208
Albany, New York 12208
(518) 262-3125
Principal Investigator: Adam Howe, MD
Albany Medical College Albany Medical Center is northeastern New York's only academic health sciences center...
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