Lime Powder Regimen (LPR) for Prevention of Renal Stone Recurrence

NCT03258190 — Phase 2, Completed, 137 participants, Chulalongkorn University

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Lime Powder Regimen Supplement Alleviates Urinary Metabolic Abnormalities to Prevent Urolithiasis Recurrence.

Registry	NCT03258190
Status	Completed
Phase	Phase 2
Study type	Interventional; randomized, parallel, masking: single, prevention
Enrollment	137 (Actual)
Sponsor	Chulalongkorn University (Other); collaborators: Sanpasitthiprasong Hospital, Burapha University
Conditions	Urolithiasis
Interventions	Lime Powder Regimen (Drug)
Dates	start 2014-07-01, primary completion 2018-06-01, completion 2018-06-30, first posted 2017-08-23, last updated 2019-02-01
Locations	1 site in Thailand

-Summary

Lime powder regimen (LPR) is a lime-derived composition enriches with citrate/citric acid and potassium. LPR was invented to treat the renal stone patients with high risk of stone recurrence after stone removal. LPR should have equal or higher efficacy and lower adverse effect than current standard medicine.

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+Detailed description

Lime powder regimen (LPR) is a mixture of lime-derive component with adjuvants containing high concentration of citrate, and moderate amount of potassium, magnesium and antioxidants. LPR was tested and verified to be very less toxic in cell culture and animal models. The clinical trial phase II showed that LPR reduced urinary metabolic abnormalities that enhance stone formation, such as hypocitraturia, hypokaliuria and acidified urine. Adverse effect of LPR was very low.

+Arms and interventions

Arm	Type	Interventions	Description
Lime Powder Regimen	Experimental	Drug: Lime Powder Regimen	Participants were asked to take LPR twice a day for 6 months
Placebo	Placebo comparator	Drug: Lime Powder Regimen	Participants were asked to take Placebo twice a day for 6 months

Lime Powder Regimen (Drug), also known as LPR supplement: LPR and placebo were randomly given to subjects for 6 months

+Outcome measures

Primary outcomes

Renal stone recurrence [6 months]: The stone recurrence after surgical removal of stone that can be detected by CT scan

+Eligibility

Sex: All, ages: 18 Years to 65 Years

Inclusion Criteria:

* Renal stone patients who were identified and stone was removed by surgical method.

Exclusion Criteria:

* Chronic kidney disease, chronic liver disease, history of coronary artery disease, or person who takes any medication that alters urinary metabolic profiles

+Locations (1)

Facility	City	Country	Status
Chulalongkorn University	Bangkok	Thailand

+Publications

Results publication: Chariyavilaskul P, Poungpairoj P, Chaisawadi S, Boonla C, Dissayabutra T, Prapunwattana P, Tosukhowong P. In vitro anti-lithogenic activity of lime powder regimen (LPR) and the effect of LPR on urinary risk factors for kidney stone formation in healthy volunteers. Urolithiasis. 2015 Apr;43(2):125-34. doi: 10.1007/s00240-015-0751-y. Epub 2015 Jan 15. PMID 25588323