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Effect of Cola on Urinary Stone Risk Factors

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00289120
First Posted: February 9, 2006
Last Update Posted: June 8, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kenneth Ogan, MD, Emory University
  Purpose
Examine the effects of cola on risks of kidney stones

Condition Intervention
Kidney Stone Drug: Cola beverage Drug: Deionized water

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Effect of Cola on Urinary Stone Risk Factors

Further study details as provided by Kenneth Ogan, MD, Emory University:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • Total Urine Volume [ 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:

    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.


  • Urinary pH [ Time Frame: at the end of each 6-day intervention in Cola and Water Phase ]

    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.



Enrollment: 13
Study Start Date: November 2003
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cola beverage
Subjects will be given 500cc of Cola twice daily.
Drug: Cola beverage
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.
Placebo Comparator: Deionized water
Subjects will be given 500cc of deionized water.
Drug: Deionized water
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

Detailed Description:
Prospective crossover study examining the risks of cola on stone risk factors.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • urolithiasis, healthy volunteer

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00289120


Locations
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Kenneth Ogan, MD Emory University
  More Information

Publications:
Responsible Party: Kenneth Ogan, MD, Associate Professor, Emory University
ClinicalTrials.gov Identifier: NCT00289120     History of Changes
Other Study ID Numbers: 0133-2003
GCRC#2403
First Submitted: February 7, 2006
First Posted: February 9, 2006
Results First Submitted: August 14, 2013
Results First Posted: July 8, 2014
Last Update Posted: June 8, 2016
Last Verified: May 2016

Keywords provided by Kenneth Ogan, MD, Emory University:
urolithiasis, cola

Additional relevant MeSH terms:
Kidney Calculi
Nephrolithiasis
Urinary Calculi
Urolithiasis
Kidney Diseases
Urologic Diseases
Calculi
Pathological Conditions, Anatomical