Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Effect of Cola on Urinary Stone Risk Factors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kenneth Ogan, MD, Emory University
ClinicalTrials.gov Identifier:
NCT00289120
First received: February 7, 2006
Last updated: June 5, 2014
Last verified: June 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Effect of Cola on Urinary Stone Risk Factors

Resource links provided by NLM:


Further study details as provided by 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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • urolithiasis, healthy volunteer

Exclusion Criteria:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Kenneth Ogan, MD, Associate Professor, Emory University
ClinicalTrials.gov Identifier: NCT00289120     History of Changes
Other Study ID Numbers: 0133-2003, GCRC#2403
Study First Received: February 7, 2006
Results First Received: August 14, 2013
Last Updated: June 5, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Emory University:
urolithiasis, cola

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

ClinicalTrials.gov processed this record on November 20, 2014