Kidney StoneNCT00289120

Effect of Cola on Urinary Stone Risk Factors

A study testing Cola beverage and Deionized water in people with Kidney Stone, run by Emory University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Examine the effects of cola on risks of kidney stones Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Kidney Stone
What is being tested?: Cola beverage and Deionized water
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 13 participants
Where: 1 siteUnited States
Study dates: Nov 2003to Oct 2011
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

urolithiasis, healthy volunteer

Who cannot join

Trial locations and contacts

1 site in 1 country.

United States1 site

Emory University
Atlanta, Georgia, 30322

Other trials in United States

About this study

Examine the effects of cola on risks of kidney stones

Read the detailed description

Prospective crossover study examining the risks of cola on stone risk factors.

Conditions: Kidney Stone
Being tested: Cola beverage, Deionized water
Keywords: urolithiasis, cola
Medical subject headings: Kidney Calculi, Urolithiasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cola beverageDrug
Subjects will be given 500cc of Cola beverage twice daily to be ingested with breakfast and dinner for six days while on a metabolic diet.There will be a three weeks interval before crossover to the other treatment arm.
Deionized waterDrug
Subjects will be given 500cc of deionized water to be ingested twice daily with breakfast and dinner for three weeks while on a metabolic diet. There will be a three weeks interval before crossover to the other treatment arm

Study groups in NCT00289120
Study group	Role	What they receive
Cola beverage	Experimental	Subjects will be given 500cc of Cola twice daily. Receives: Drug: Cola beverage
Deionized water	Placebo comparator	Subjects will be given 500cc of deionized water. Receives: Drug: Deionized water

What is being measured

The primary outcome is the main question the study is designed to answer.

The Plasma and Urine Parameters
The Plasma and Urine Parameters that were assessed at the end of cola and water (arms) phase:
Plasma Parameters:
CA (mg per dL) GLU (mg per dL) BUN (mg per dL) Cr (mg per dL) Prot (mg per dL) ALB (mg per dL)
Urine Parameters:
uCa (mg per dL) uMg (mg per dL) uP (mg per dL) uCr (mg per dL) uCit (mg per dL) uOx (mg per dL) uUA (mg per dL)
The parameters were consolidated into the one value as a mean of all the values in the phase or group (Table 3) and later for longitudinal analysis as a mean of all the values in the phase for each participant (Table 4).
measure of dispersion was standard deviation.
Measured: at the end of each 6-day intervention in Cola and Water Phase
The Plasma and Urine Parameters
The Plasma and Urine Parameters that were assessed at the end of cola and water (arms) phase:
Plasma Parameters:
Na (mEq per L) K (mEq per L) CL (mEq per L) CO2(mEq per L) AG (mEq per L)
The parameters were consolidated into the one value as a mean of all the values in the phase or group (Table 3) and later for longitudinal analysis as a mean of all the values in the phase for each participant (Table 4).
measure of dispersion was standard deviation.
Measured: at the end of 6-day intervention of Cola and water phase
The Plasma Osmolarity
The Plasma osmolarity that were assessed at the end of cola and water (arms) phase:
Plasma Parameters:
OSM (mOsm/L)
The parameters were consolidated into the one value as a mean of all the values in the phase or group (Table 3) and later for longitudinal analysis as a mean of all the values in the phase for each participant (Table 4).
measure of dispersion was standard deviation.
Measured: at the end of 6-day intervention of cola and water phase
The Plasma and Urine Parameters
The Urine Parameters that were assessed at the end of cola and water (arms) phase:
Urine Parameters:
uNa (mEq per d) uK (mEq per d)
The parameters were consolidated into the one value as a mean of all the values in the phase or group (Table 3) and later for longitudinal analysis as a mean of all the values in the phase for each participant (Table 4).
measure of dispersion was standard deviation.
Measured: at the end of 6-day intervention of Cola and water phase

Secondary outcomes (2)

Total Urine Volume
The Plasma and Urine Parameters that were assessed at the end of cola and water (arms) phase:
Urine Parameters:
Total Urine Volume (mL/day)
The parameters were consolidated into the one value as a mean of all the values in the phase or group (Table 3) and later for longitudinal analysis as a mean of all the values in the phase for each participant (Table 4).
measure of dispersion was standard deviation.
Measured: at the end of each 6-day intervention in Cola and Water Phase
Urinary pH
The Urine pH that were assessed at the end of cola and water (arms) phase The parameters were consolidated into the one value as a mean of all the values in the phase or group (Table 3) and later for longitudinal analysis as a mean of all the values in the phase for each participant (Table 4).
measure of dispersion was standard deviation.
Measured: at the end of each 6-day intervention in Cola and Water Phase

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2003Oct 2011

First posted9 Feb 2006 (estimated)
Study startNov 2003
Primary completionOct 2011
Study completionOct 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Kidney StoneStudies of the same condition, open and under way.
More trials run by Emory 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: Health services research
Allocation: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 13 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00289120
Sponsor's protocol ID: 0133-2003
Other IDs: GCRC#2403
Status last verified: May 2016
First submitted: 7 Feb 2006
Last updated: 8 Jun 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Herrel L, Pattaras J, Solomon T, Ogan K. Urinary stone risk and cola consumption. Urology. 2012 Nov;80(5):990-4. doi: 10.1016/j.urology.2012.07.003. Epub 2012 Sep 25.
PubMed 23017784

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 8 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Cola on Urinary Stone Risk Factors
ClinicalTrials.gov ID: NCT00289120
Acronym / sponsor ID: 0133-2003
Conditions: Kidney Stone
Keywords: urolithiasis, cola
Study type: Interventional
Recruitment status: Completed
Enrolment: 13 participants (actual)
Lead sponsor: Emory UniversityUniversity, hospital or other
Study start: Nov 2003
Primary completion: Oct 2011 (actual)
Study completion: Oct 2011 (actual)
First posted: 9 Feb 2006 (estimated)
Results: Posted 8 Jul 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Examine the effects of cola on risks of kidney stones

Detailed description

Prospective crossover study examining the risks of cola on stone risk factors.

Study design

Primary purpose: Health services research
Allocation: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Cola beverage	Experimental	Drug: Cola beverageSubjects will be given 500cc of Cola twice daily.
Deionized water	Placebo comparator	Drug: Deionized waterSubjects will be given 500cc of deionized water.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

urolithiasis, healthy volunteer

Key exclusion criteria (1 listed)

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
Cola beverageSubjects will be given 500cc of Cola beverage twice daily to be ingested with breakfast and dinner for six days while on a metabolic diet.There will be a three weeks interval before crossover to the other treatment arm.	Drug	Cola beverage
Deionized waterSubjects will be given 500cc of deionized water to be ingested twice daily with breakfast and dinner for three weeks while on a metabolic diet. There will be a three weeks interval before crossover to the other treatment arm	Drug	Deionized water

Primary outcome

The Plasma and Urine Parameters
Time frame: at the end of each 6-day intervention in Cola and Water Phase
The Plasma and Urine Parameters that were assessed at the end of cola and water (arms) phase: Plasma Parameters: CA (mg per dL) GLU (mg per dL) BUN (mg per dL) Cr (mg per dL) Prot (mg per dL) ALB (mg per dL) Urine Parameters: uCa (mg per dL) uMg (mg per dL) uP (mg per dL) uCr (mg per dL) uCit (mg per dL) uOx (mg per dL) uUA (mg per dL) The parameters were consolidated into the one value as a mean of all the values in the phase or group (Table 3) and later for longitudinal analysis as a mean of all the values in the phase for each participant (Table 4). measure of dispersion was standard deviation.
The Plasma and Urine Parameters
Time frame: at the end of 6-day intervention of Cola and water phase
The Plasma and Urine Parameters that were assessed at the end of cola and water (arms) phase: Plasma Parameters: Na (mEq per L) K (mEq per L) CL (mEq per L) CO2(mEq per L) AG (mEq per L) The parameters were consolidated into the one value as a mean of all the values in the phase or group (Table 3) and later for longitudinal analysis as a mean of all the values in the phase for each participant (Table 4). measure of dispersion was standard deviation.
The Plasma Osmolarity
Time frame: at the end of 6-day intervention of cola and water phase
The Plasma osmolarity that were assessed at the end of cola and water (arms) phase: Plasma Parameters: OSM (mOsm/L) The parameters were consolidated into the one value as a mean of all the values in the phase or group (Table 3) and later for longitudinal analysis as a mean of all the values in the phase for each participant (Table 4). measure of dispersion was standard deviation.
The Plasma and Urine Parameters
Time frame: at the end of 6-day intervention of Cola and water phase
The Urine Parameters that were assessed at the end of cola and water (arms) phase: Urine Parameters: uNa (mEq per d) uK (mEq per d) The parameters were consolidated into the one value as a mean of all the values in the phase or group (Table 3) and later for longitudinal analysis as a mean of all the values in the phase for each participant (Table 4). measure of dispersion was standard deviation.

2 secondary outcomes

Total Urine Volume
Time frame: at the end of each 6-day intervention in Cola and Water Phase
Urinary pH
Time frame: at the end of each 6-day intervention in Cola and Water Phase

Results and safety

Results posted to the registry on 8 Jul 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cola First, Then Water	13	13

Primary outcome: The Plasma and Urine Parameters

Time frame: at the end of each 6-day intervention in Cola and Water Phase. Mean (Standard Deviation). Unit: mg per dL

Measure	Cola n = 13	Water n = 13
Plasma Proteins	6800 (500)	6800 (500)
Plasma Albumin	3700 (300)	3700 (300)
Plasma Calcium	9.1 (0.3)	9.0 (0.2)
Mean Plasma Glucose	92.8 (9)	95.2 (15.7)
blood urea nitrogen	10.1 (4.5)	11.1 (5.0)
Plasma Creatinine	0.9 (0.2)	2.1 (2.9)
Urinary Calcium	124.3 (74.5)	146.4 (86.9)
Urinary Magnesium	94.6 (43.7)	106.8 (49.9)

Primary outcome: The Plasma and Urine Parameters

Time frame: at the end of 6-day intervention of Cola and water phase. Mean (Standard Deviation). Unit: mEq/L

Measure	Water n = 13	Cola n = 13
Plasma sodium	138.3 (2.5)	139.1 (2.3)
Plasma Potassium	3.8 (0.2)	3.9 (0.4)
Plasma Chlorides	104.8 (2.3)	105.2 (3.0)
Plasma CO2	26.1 (2.0)	26.4 (2.4)
Plasma AG	7.3 (1.2)	7.3 (1.6)

Primary outcome: The Plasma Osmolarity

Time frame: at the end of 6-day intervention of cola and water phase. Mean (Standard Deviation). Unit: mOsm/L

Measure	Water n = 13	Cola n = 13
Value	276.5 (4.8)	277.5 (5.0)

Primary outcome: The Plasma and Urine Parameters

Time frame: at the end of 6-day intervention of Cola and water phase. Mean (Standard Deviation). Unit: mEq per d

Measure	Water n = 13	Cola n = 13
Urinary sodium	139.9 (40.0)	103.9 (43.5)
Urinary Potassium	49.3 (31.4)	41.4 (17.1)

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cola Beverage Phase	0 of 13 (0%)	0 of 13 (0%)	Not reported
Deionized Water Drinking Phase	0 of 13 (0%)	0 of 13 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 23017784Herrel L, Pattaras J, Solomon T, Ogan K. Urinary stone risk and cola consumption. Urology. 2012 Nov;80(5):990-4. doi: 10.1016/j.urology.2012.07.003. Epub 2012 Sep 25.

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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.

Kenneth Ogan, MD principal investigator

Emory 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 Cola beverage and Deionized water in people with Kidney Stone, run by Emory 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 1 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 8 Jun 2016. 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 8 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

The Plasma and Urine Parameters (time frame: at the end of each 6-day intervention in Cola and Water Phase). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00289120, which also lists 1 linked publication.

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 8 Jun 2016.