Treatment for Calcium Phosphate Kidney Stone Disease

NCT01754779 | Completed Phase 2 Results DMC

• 2 other identifiers: 032012-058R21DK097476-01
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will examine in two studies whether citric acid or potassium citrate can reduce calcium phosphate saturation in urine of Calcium Phosphate stone formers.

Conditions

Calcium Phosphate Kidney Stones

Keywords

calcium phosphate; urolithiasis; kidney stones; hypercalciuria

Outcome Measures

Primary Outcomes (1)

• Urinary Calcium Phosphate Saturation

  This variable represents a ratio of the calcium phosphate saturation in a given urine sample to the calcium phosphate saturation at the point of precipitation and hence this measure has no units.

  2 weeks

Study Arms (6)

Placebo, then Citric Acid, then Potassium Citrate

EXPERIMENTAL

Participants will receive at random, First intervention (1 week), then experience a washout period (1 week) and then receive Second Intervention (1 week) followed by another washout period of 1 week to finally receive the Third Intervention (1 week)

Dietary Supplement: Placebo; Dietary Supplement: Citric Acid; Dietary Supplement: Potassium Citrate

Placebo, then Potassium Citrate, then Citric Acid

EXPERIMENTAL

Participants will receive at random, First intervention (1 week), then experience a washout period (1 week) and then receive Second Intervention (1 week) followed by another washout period of 1 week to finally receive the Third Intervention (1 week)

Dietary Supplement: Placebo; Dietary Supplement: Citric Acid; Dietary Supplement: Potassium Citrate

Potassium Citrate, then Placebo, then Citric Acid

EXPERIMENTAL

Participants will receive at random, First intervention (1 week), then experience a washout period (1 week) and then receive Second Intervention (1 week) followed by another washout period of 1 week to finally receive the Third Intervention (1 week)

Dietary Supplement: Placebo; Dietary Supplement: Citric Acid; Dietary Supplement: Potassium Citrate

Potassium Citrate, then Citric Acid, then Placebo

EXPERIMENTAL

Participants will receive at random, First intervention (1 week), then experience a washout period (1 week) and then receive Second Intervention (1 week) followed by another washout period of 1 week to finally receive the Third Intervention (1 week)

Dietary Supplement: Placebo; Dietary Supplement: Citric Acid; Dietary Supplement: Potassium Citrate

Citric Acid, then Potassium Citrate, then Placebo

EXPERIMENTAL

Participants will receive at random, First intervention (1 week), then experience a washout period (1 week) and then receive Second Intervention (1 week) followed by another washout period of 1 week to finally receive the Third Intervention (1 week)

Dietary Supplement: Placebo; Dietary Supplement: Citric Acid; Dietary Supplement: Potassium Citrate

Citric Acid, then Placebo, then Potassium Citrate

EXPERIMENTAL

Participants will receive at random, First intervention (1 week), then experience a washout period (1 week) and then receive Second Intervention (1 week) followed by another washout period of 1 week to finally receive the Third Intervention (1 week)

Dietary Supplement: Placebo; Dietary Supplement: Citric Acid; Dietary Supplement: Potassium Citrate

Interventions

Placebo DIETARY_SUPPLEMENT

3 tablets twice daily of matching placebo during the placebo phase.

Citric Acid, then Placebo, then Potassium Citrate; Citric Acid, then Potassium Citrate, then Placebo; Placebo, then Citric Acid, then Potassium Citrate; Placebo, then Potassium Citrate, then Citric Acid; Potassium Citrate, then Citric Acid, then Placebo; Potassium Citrate, then Placebo, then Citric Acid

Citric Acid DIETARY_SUPPLEMENT

3, 10 mEq tablets of H3Cit twice daily during the H3Cit phase (60 mEq H3Cit per day)

Citric Acid, then Placebo, then Potassium Citrate; Citric Acid, then Potassium Citrate, then Placebo; Placebo, then Citric Acid, then Potassium Citrate; Placebo, then Potassium Citrate, then Citric Acid; Potassium Citrate, then Citric Acid, then Placebo; Potassium Citrate, then Placebo, then Citric Acid

Potassium Citrate DIETARY_SUPPLEMENT

2, 10 mEq K3Cit tablets and 1 placebo tablet twice daily during the K3Cit phase (40 mEq K3Cit per day)

Citric Acid, then Placebo, then Potassium Citrate; Citric Acid, then Potassium Citrate, then Placebo; Placebo, then Citric Acid, then Potassium Citrate; Placebo, then Potassium Citrate, then Citric Acid; Potassium Citrate, then Citric Acid, then Placebo; Potassium Citrate, then Placebo, then Citric Acid

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aim 1
• Hypocitraturic CaP stone formers
• urine citrate \<320mg/d
• elevated pH as 24-hr urine pH above 6.40
• \>21 years
• Aim 2
• Hypercalciuric CaP stone formers
• hr urine calcium \>250mg/d in women and \>300mg/d in men prior to indapamide use
• high pH as \>6.40 in the absence of urinary tract infection
• \>21 years

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390-8885, United States

Location

Related Publications (1)

• Doizi S, Poindexter JR, Pearle MS, Blanco F, Moe OW, Sakhaee K, Maalouf NM. Impact of Potassium Citrate vs Citric Acid on Urinary Stone Risk in Calcium Phosphate Stone Formers. J Urol. 2018 Dec;200(6):1278-1284. doi: 10.1016/j.juro.2018.07.039. Epub 2018 Jul 20.

  PMID: 30036516 BACKGROUND

MeSH Terms

Conditions

Urolithiasis; Kidney Calculi; Hypercalciuria

Interventions

Citric Acid; Potassium Citrate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

The second study (in hypercalciuric Cap stone formers) was never conducted due to difficulties in recruitment and limited budget.

Results Point of Contact

• Title: Dr. Naim Maalouf
• Organization: UT Southwestern Medical Center

naim.maalouf@utsouthwestern.edu

214/648-2954

Study Officials

• Naim M Maalouf, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: December 14, 2012
• First Posted: December 21, 2012
• Study Start: July 1, 2012
• Primary Completion: February 16, 2023
• Study Completion: February 16, 2023
• Last Updated: April 4, 2024
• Results First Posted: April 4, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)