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Hydroxycitrate: A Novel Therapy for Calcium Phosphate Urinary Stones

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ClinicalTrials.gov Identifier: NCT06003348
Recruitment Status : Recruiting
First Posted : August 21, 2023
Last Update Posted : April 12, 2024
Sponsor:
Information provided by (Responsible Party):
Naim Maalouf, University of Texas Southwestern Medical Center

Study Description
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Brief Summary:
This study tests whether hydroxycitrate, a molecule closely related to citrate, can reduce calcium phosphate stone recurrence.

Condition or disease Intervention/treatment Phase
Calcium Phosphate Kidney Stones Dietary Supplement: OHCit- standard dose Drug: Potassium Citrate Drug: Placebo Dietary Supplement: OHCit- low dose Phase 4

Detailed Description:

In this double-blind, placebo-controlled, randomized, crossover study, each participant will undergo 4 phases of study, with the order randomized by a blocked randomization scheme. The 4 phases will be Placebo, Super CitriMax (hydroxycitrate) OHCit low dose, OHCit standard dose, or Potassium Citrate. Randomization will be stratified based on sex, concomitant thiazide use, and concomitant alkali use.

Each phase will be 1 week in duration, during which subjects will take assigned study medications. A minimum 1-week washout period will be imposed between phases. During the first 2 days of each phase, subjects will be instructed to adhere to a prescribed diet. On the last 5 days of each phase, subjects will be kept on a constant metabolic diet. Use of metabolic diet is essential to eliminate confounders that could occur from changes in dietary intake across phases. During the final two study days (days 6-7), two 24-hr urines will be collected for urine biochemistry and crystallization studies. Fasting blood will be obtained at the end of the last urine collection.

Study Medications: Subjects will receive three tablets twice daily during each phase. These will consist of either placebo, Potassium Citrate (KCit), or Super CitriMax (OHCit). Study tablets will be prepared by a compounding pharmacy, with placebo tablets similar in appearance and size to the active medication tablets.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: In this double-blind, placebo-controlled, randomized, crossover study, each participant will undergo 4 phases of study, with the order randomized by a blocked randomization scheme. The 4 phases will be Placebo, Super CitriMax (OHCit) low dose, Super CitriMax (OHCit) standard dose, or Potassium Citrate. Randomization will be stratified based on sex, concomitant thiazide use, and concomitant alkali use.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Hydroxycitrate: A Novel Therapy for Calcium Phosphate Urinary Stones
Actual Study Start Date : December 13, 2023
Estimated Primary Completion Date : May 31, 2028
Estimated Study Completion Date : August 31, 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium Potassium

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Potassium Citrate (Urocit®-K)
Potassium Citrate KCit 10 mEq 2 tabs, twice daily and Placebo 1 tab, twice daily Total Daily Dose: Citrate 40 mEq/d
 Drug: Potassium Citrate
10 mEq Extended-release tablets for oral use
Other Name: Urocit®-K
Experimental: Super CitriMax; OHCit-standard dose
Super CitriMax 7 mEq 3 tabs, twice daily Total Daily Dose: OHCit 42 mEq/d
 Dietary Supplement: OHCit- standard dose
Hydroxycitrate Over-the-counter supplement, not FDA approved or regulated.
Other Name: Super Citrimax
Experimental: Super CitriMax; OHCit-low dose
Super CitriMax 7 mEq 2 tabs, twice daily And Placebo 1 tab, twice daily Total Daily Dose: OHCit 28 mEq/d
 Dietary Supplement: OHCit- low dose
Hydroxycitrate Over-the-counter supplement, not FDA approved or regulated.
Other Name: Super Citrimax
Placebo Comparator: Placebo
Placebo 3 tablets twice daily Total Daily Dose: None
 Drug: Placebo
Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Formation product (FP) for Calcium Phosphate [ Time Frame: After 1 week of treatment ]

    FP is obtained by adding increasing amounts of Calcium Chloride (CaCl2) to a series of urine aliquots maintained at constant pH for 2 hours, and is identified by the point at which calcium phosphate (CaP) precipitates as detected by an absorbance microplate reader.

    Calculated supersaturation using [Calcium] and [Phosphate] at that point represents FP.



Secondary Outcome Measures :
  1. Crystal growth of Calcium Phosphate [ Time Frame: After 1 week of treatment ]
    We will assess crystal growth (CG) of CaP after seeding urine with a small amount of brushite (0.25 mg/ml urine) and incubating at 37°C for 3 hours (representing steady state) under constant stirring. A decrement in [Calcium]×[Phosphate] after seeding signifies crystal growth, while a [Calcium]×[Phosphate] increment represents crystal dissolution.

  2. Calcium Phosphate supersaturation [ Time Frame: After 1 week of treatment ]
    Supersaturation of calcium phosphate will be assessed by Joint Expert Speciation System (JESS).


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Calcium Phosphate stone formers

Exclusion Criteria:

  • History of recurrent urinary tract infections
  • Chronic diarrhea
  • Estimated Glomerular Filtration Rate (eGFR) < 45 ml/min/1.73 m2
  • History of primary hyperparathyroidism
  • Hypokalemia
  • Hyperkalemia
  • Pregnancy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06003348


Contacts
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Contact: NAIM M MAALOUF, MD 214/648-2954 naim.maalouf@utsouthwestern.edu
Contact: Miranda King 2146482117 Miranda.King@utsouthwestern.edu

Locations
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United States, Texas
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390-8885
Contact: Naim M Maalouf, MD         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
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Principal Investigator: NAIM M MAALOUF University of Texas Southwestern Medical Center
More Information
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Responsible Party: Naim Maalouf, Professor, Internal Medicine, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT06003348    
Other Study ID Numbers: 2023-0339
First Posted: August 21, 2023    Key Record Dates
Last Update Posted: April 12, 2024
Last Verified: April 2024

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Naim Maalouf, University of Texas Southwestern Medical Center:
Urolithiasis
Calcium phosphate
Citrate
Acid-base
Additional relevant MeSH terms:
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Kidney Calculi
Urinary Calculi
Urolithiasis
Calculi
Pathological Conditions, Anatomical
Nephrolithiasis
Kidney Diseases
Urologic Diseases
Female Urogenital Diseases
 Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases
Potassium Citrate
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Expectorants
Respiratory System Agents