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Completed

NCT Number: NCT00289120

Effect of Cola on Urinary Stone Risk Factors

Examine the effects of cola on risks of kidney stones

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Key information

Conditions

Kidney Stone Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Calculi Kidney Diseases Male Urogenital Diseases Nephrolithiasis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Urinary Calculi Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emory University

Atlanta, Georgia, 30322, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • urolithiasis, healthy volunteer

Exclusion criteria

-

Treatment and study plan

Cola beverage

Drug

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 water

Drug

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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 outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Important dates

Study start
2003
Primary completion
2011
Study completion
2011
First posted
Feb 9, 2006
Registry last updated
Jun 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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