NCT01330940

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 7, 2011

Completed
Last Updated

September 10, 2012

Status Verified

September 1, 2012

Enrollment Period

8 months

First QC Date

April 4, 2011

Last Update Submit

September 6, 2012

Conditions

Kidney StonesNephrolithiasisUrolithiasis

Keywords

Kidney stonesCalciumcitrate

Outcome Measures

Primary Outcomes (1)

  • Change in urine citrate content

    Citrate is measured in 24h urine sample and expressed as mg/day

    1 week

Secondary Outcomes (1)

  • Change in urine pH

    One week

Study Arms (2)

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

Orange sodaDIETARY_SUPPLEMENT

32 ounces per day

Water drinkingorange soda drinking

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York Harbor VA Medical Center

New York, New York, 10010, United States

Location

MeSH Terms

Conditions

Kidney CalculiNephrolithiasisUrolithiasis

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • David S Goldfarb, MD

    New York Harbor VA Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Nephrology

Study Record Dates

First Submitted

April 4, 2011

First Posted

April 7, 2011

Study Start

November 1, 2009

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

September 10, 2012

Record last verified: 2012-09

Locations

US(1)