A Dietary Source of Potassium Citrate to Resolve Hypocitraturia and Aciduria in Patients With Kidney Stones

NCT03984409 | Completed DMC

• 1 other identifier: 1903221743
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 2

Brief Summary

Patients with nephrolithiasis and evidence of hypocitraturia or aciduria who would otherwise be started on potassium citrate, can achieve similar urine alkalization with 500-1000 mL of daily low calorie orange juice consumption.

Conditions

Kidney Calculi

Outcome Measures

Primary Outcomes (2)

• Urine alkalization from Kroger low calorie orange juice beverage

  The primary endpoint of interest will be the changes in urinary citrate while consuming Kroger low calorie orange juice beverage compared to potassium citrate therapy.

  9 weeks from enrollment

• Urine alkalization from Kroger low calorie orange juice beverage

  The primary endpoint of interest will be the changes in urinary pH while consuming Kroger low calorie orange juice beverage compared to potassium citrate therapy.

  9 weeks from enrollment

Study Arms (2)

Group 1

ACTIVE COMPARATOR

Potassium citrate x 7days Off therapy x 7 days 500 mL low calorie orange juice beverage x 7 days 1000 mL low calorie orange juice beverage x 7 days Return to potassium citrate therapy Litholink urine collection to be performed after each 7 days treatment

Dietary Supplement: Kroger low calorie orange juice beverage

Group 2

ACTIVE COMPARATOR

500 mL low calorie orange juice beverage x 7 days 1000 mL low calorie orange juice beverage x 7 days Off therapy x 7 days Potassium citrate x 7days Continue on potassium citrate therapy Litholink urine collection to be performed after each 7 days treatment

Dietary Supplement: Kroger low calorie orange juice beverage

Interventions

Kroger low calorie orange juice beverage DIETARY_SUPPLEMENT

Kroger low calorie orange juice beverage will be consumed for 7 days followed by a 24 hour urine collection with Litholink to see if urine alkalization similar to potassium citrate can be achieved

Also known as: potassium citrate

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between 18 and 75 year of age.
• History of kidney stone disease with available stone analysis
• Evidence of aciduria or hypocitraturia on 24 hour urinalysis (24 hr citrate male \<450 mg/day female \<550 mg/day) or aciduria (urine pH \< 5.8)
• Ability to drink Kroger low calorie orange juice beverage
• If subject with history of diabetes mellitus, must have HgA1c \< 7.5 and willing to check daily blood sugars.

You may not qualify if:

• Less than 18 or older than 75 years of age
• Allergies to low calorie orange juice, including intolerance because of side effects including (but not limited to): gastrointestinal symptoms, headaches, weight gain, unable to drink because of taste.
• Poorly controlled diabetic (HgA1c \>7.5)
• No evidence of hypocitraturia or aciduria on 24 hour urinalysis
• Unable to afford potassium citrate therapy or tolerate medication because of side effects.
• Unwilling to perform 3 24-hour urine collections

Sponsors & Collaborators

• Indiana University: lead

Study Sites (2)

Indiana University Health Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

Indiana University Health Physicians Urology

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Kidney Calculi

Interventions

Potassium Citrate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Citric Acid; Citrates; Tricarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Tim Large, MD

  Indiana University Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Group 1 kcit x 7 days ↓ Litholink on day 7 ↓ off therapy x 7 days ↓ OJ 500 ML + 1.5L water /day x 7 days ↓ Litholink on day 7 ↓ OJ 1000 ML + 1L water /day x 7 days ↓ Litholink on day 7 Return to kcit therapy Group 2 OJ 500 ML + 1.5L water /day x 7 days ↓ Litholink on day 7 ↓ OJ 1000 ML + 1L water /day x 7 days ↓ Litholink on day 7 ↓ off therapy x 7 days ↓ kcit x 7 days ↓ Litholink on day 7 Continue on kcit therapy

Study Record Dates

• First Submitted: May 22, 2019
• First Posted: June 13, 2019
• Study Start: June 1, 2019
• Primary Completion: August 31, 2020
• Study Completion: November 1, 2020
• Last Updated: November 19, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)