Effect of Cola on Urinary Stone Risk Factors

Study Overview
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Brief Summary
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Examine the effects of cola on risks of kidney stones

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

Official Title
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Effect of Cola on Urinary Stone Risk Factors

Conditions
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Kidney Stone

Intervention / Treatment
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* Drug: Cola beverage
* Drug: Deionized water


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: urolithiasis, healthy volunteer Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cola beverage<br>Subjects will be given 500cc of Cola twice daily. | Drug: Cola beverage<br>* 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.<br>|
| Placebo Comparator: Deionized water<br>Subjects will be given 500cc of deionized water. | Drug: Deionized water<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | at the end of 6-day intervention of Cola and water phase | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | at the end of each 6-day intervention in Cola and Water Phase | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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urolithiasis, cola