Effect of Diet Orange Soda on Urinary Lithogenicity | NCT01330940

Studies
Effect of Diet Orange Soda on Urinary Lithogenicity

NCT01330940

Sponsor

VA New York Harbor Healthcare System

Status

Completed

Last Update Posted

Sep 10, 2012Estimated

Enrollment

12Actual

Phase

Not Applicable

Conditions

Kidney Stones
Nephrolithiasis
Urolithiasis

Interventions

Orange soda

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2009

Primary Completion Date

Jul 2010Actual

Completion Date

Jul 2010Actual

First Submitted Date

Apr 4, 2011

First Submission Date that Met QC Criteria

Apr 6, 2011

First Posted Date

Apr 7, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 6, 2012

Last Update Posted Date

Sep 10, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

David S. Goldfarb, M.D., Chief, Nephrology, VA New York Harbor Healthcare SystemPrincipal Investigator

Lead Sponsor

VA New York Harbor Healthcare SystemFED

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Beverages containing citrate may be useful in increasing urine citrate content and urine pH. Such changes in urine chemistry could help prevent kidney stones. Diet orange soda has more citrate than other similar beverages. The investigators are interested in whether diet soda will improve urine chemistry in the appropriate manner.

Detailed Description

The effect of orange soda compared with water in changing 24 hour urine citrate excretion in mg/day will be determined.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Water drinking	Placebo Comparator	32 ounces of water/24 hours	Dietary Supplement: Orange soda
orange soda drinking	Active Comparator	32 ounces orange soda	Dietary Supplement: Orange soda

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Orange soda	Dietary Supplement	32 ounces per day	Water drinking orange soda drinking

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in urine citrate content	Citrate is measured in 24h urine sample and expressed as mg/day	1 week

Secondary Outcomes

Measure	Description	Time Frame
Change in urine pH	urine pH is measured in a 24h urine sample and has no units	One week

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18-65 years old
able to sign consent
ability to reliably urinate into a vessel and measure urine volume

Exclusion Criteria:

prior history of nephrolithiasis
a known history of metabolic bone disease
hyperthyroidism
hyperparathyroidism or chronic kidney disease
current use of diuretics
current use of potassium citrate or other oral alkali supplementation and
use of calcium supplementation that could not be stopped

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David S Goldfarb, MD	New York Harbor VA Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
New York Harbor VA Medical Center		New York	New York	10010	United States

Condition Browse Module

MeSH Terms

ID	Term
D007669	Kidney Calculi
D053040	Nephrolithiasis
D052878	Urolithiasis

Ancestor Terms

ID	Term
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided