Hydroxycitrate: A Novel Therapy for Calcium Phosphate Urinary Stones

Conditions

• Calcium Phosphate Kidney Stones

Eligibility Criteria

Sex

ALL

Age

21 Years - 99 Years

Healthy Volunteers

Not accepted

Interventions

• OHCit- standard dose — DIETARY_SUPPLEMENT
  Hydroxycitrate Over-the-counter supplement, not FDA approved or regulated.
• Potassium Citrate — DRUG
  10 mEq Extended-release tablets for oral use
• Placebo — DRUG
  Placebo
• OHCit- low dose — DIETARY_SUPPLEMENT
  Hydroxycitrate Over-the-counter supplement, not FDA approved or regulated.

Study Details

This study tests whether hydroxycitrate, a molecule closely related to citrate, can reduce calcium phosphate stone recurrence.

Key Dates

Start date

Dec 13, 2023

Status verified

Jun 2026

Primary completion

May 31, 2028

Completion

Aug 31, 2028

Study Design

Enrollment

25 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

Arms

• 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
• Experimental: Super CitriMax; OHCit-standard dose
  Super CitriMax 7 mEq 3 tabs, twice daily Total Daily Dose: OHCit 42 mEq/d
• 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
• Placebo Comparator: Placebo
  Placebo 3 tablets twice daily Total Daily Dose: None

Primary Outcome Measure

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

Central Contacts

• NAIM M MAALOUF, MD
  214/648-2954
  [email protected]
• Miranda King
  2146482117
  [email protected]

Locations (1)

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