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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
February 7, 2006
February 9, 2006
August 14, 2013
July 8, 2014
June 8, 2016
November 2003
October 2011   (Final data collection date for primary outcome measure)
  • 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.

kidney stone
Complete list of historical versions of study NCT00289120 on ClinicalTrials.gov Archive Site
  • 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.

Not Provided
Not Provided
Not Provided
 
Effect of Cola on Urinary Stone Risk Factors
Effect of Cola on Urinary Stone Risk Factors
Examine the effects of cola on risks of kidney stones
Prospective crossover study examining the risks of cola on stone risk factors.
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Kidney Stone
  • 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.
  • 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
  • Experimental: Cola beverage
    Subjects will be given 500cc of Cola twice daily.
    Intervention: Drug: Cola beverage
  • Placebo Comparator: Deionized water
    Subjects will be given 500cc of deionized water.
    Intervention: Drug: Deionized water
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13
October 2011
October 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • urolithiasis, healthy volunteer

Exclusion Criteria:

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00289120
0133-2003
GCRC#2403
No
Not Provided
Not Provided
Kenneth Ogan, MD, Emory University
Emory University
Not Provided
Principal Investigator: Kenneth Ogan, MD Emory University
Emory University
May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP