Effect of Cola on Urinary Stone Risk Factors

NCT00289120 | Completed Results

• 2 other identifiers: 0133-2003GCRC#2403
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

Examine the effects of cola on risks of kidney stones

Conditions

Kidney Stone

Keywords

urolithiasis, cola

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Total Urine Volume

  at the end of each 6-day intervention in Cola and Water Phase

• Urinary pH

  at the end of each 6-day intervention in Cola and Water Phase

Study Arms (2)

Cola beverage

EXPERIMENTAL

Subjects will be given 500cc of Cola twice daily.

Drug: Cola beverage

Deionized water

PLACEBO COMPARATOR

Subjects will be given 500cc of deionized water.

Drug: Deionized water

Interventions

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.

Cola beverage

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

Deionized water

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• urolithiasis, healthy volunteer

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Emory University

Atlanta, Georgia, 30322, United States

Location

Related Publications (1)

• 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.

  PMID: 23017784 RESULT

MeSH Terms

Conditions

Kidney Calculi; Urolithiasis

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Kenneth Ogan
• Organization: Emory University

kogan@emory.edu

404-778-4898

Study Officials

• Kenneth Ogan, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 7, 2006
• First Posted: February 9, 2006
• Study Start: November 1, 2003
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: June 8, 2016
• Results First Posted: July 8, 2014

Record last verified: 2016-05

Locations

US (1)