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| ID | Type | Description | Link |
|---|---|---|---|
| GCRC#2403 |
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Examine the effects of cola on risks of kidney stones
Prospective crossover study examining the risks of cola on stone risk factors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cola beverage | Experimental | Subjects will be given 500cc of Cola twice daily. |
|
| Deionized water | Placebo Comparator | Subjects will be given 500cc of deionized water. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
-
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth Ogan, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University | Atlanta | Georgia | 30322 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23017784 | Result | 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. |
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Normal subjects and calcium oxalate stone-formers were included.
Recruited patients of Emory University Department of Urology
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| ID | Title | Description |
|---|---|---|
| FG000 | Cola First, Then Water | Phase 1: 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 wash-out period before patients entere phase 2 of thre study. Phase 2: Subjects will be given 500cc of deionized water twice daily to be ingested with breakfast and dinner for six days while on a metabolic diet. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Thirteen subjects, including 10 normal subjects and 3 calcium oxalate stone-formers were enrolled in this prospective cross-over study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cola First, Then Water | Phase 1: 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 3-week wash out period before subjects enter phase 2 of the study. Phase 2: Subjects will be given 500 cc of deionized water beverage twice daily to be ingested with breakfast and dinner for six days while on a metabolic diet. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | mg per dL | at the end of each 6-day intervention in Cola and Water Phase |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cola Beverage Phase | Subjects were given 500cc of Cola twice daily to be ingested with breakfast and dinner for six days while on a metabolic diet. There will be a three weeks interval (wash out period) before crossover to the other treatment arm. No adverse event reported. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kenneth Ogan | Emory University | 404-778-4898 | kogan@emory.edu |
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| ID | Term |
|---|---|
| D007669 | Kidney Calculi |
| D052878 | Urolithiasis |
| ID | Term |
|---|---|
| D053040 | Nephrolithiasis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| 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 |
|
| at the end of 6-day intervention of Cola and water phase |
| 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 |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Study participants | Number | participants |
|
| OG001 |
| Water |
participants ingested 500 mL of deionized water twice daily, with breakfast and dinner. |
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | mEq/L | at the end of 6-day intervention of Cola and water phase |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | mOsm/L | at the end of 6-day intervention of cola and water phase |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | mL/day | at the end of each 6-day intervention in Cola and Water Phase |
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|
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| Secondary | 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. | Posted | Mean | Standard Deviation | pH | at the end of each 6-day intervention in Cola and Water Phase |
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|
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| Primary | 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. | Posted | Mean | Standard Deviation | mEq per d | at the end of 6-day intervention of Cola and water phase |
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| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | Deionized Water Drinking Phase | Subjects were given 500cc of regular deionized water twice daily to be ingested with breakfast and dinner for six days while on a metabolic diet. No adverse event reported. | 0 | 13 | 0 | 13 |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D014545 | Urinary Calculi |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Plasma Chlorides |
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| Plasma CO2 |
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| Plasma AG |
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