Nephrolithiasis Prevention by Lemon Juice (LIMONE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Mario Negri Institute for Pharmacological Research
Sponsor:
Information provided by (Responsible Party):
Mario Negri Institute for Pharmacological Research
ClinicalTrials.gov Identifier:
NCT01217372
First received: September 30, 2010
Last updated: September 17, 2014
Last verified: September 2014
  Purpose

Calcium oxalate nephrolithiasis is a relatively common disease. The prevalence in the general population may range from 10 to 12 percent, and 0.4 to 1 percent of new cases are reported every year according to different series. Without specific pharmacological therapy, the recurrence rate in patient with established diagnosis of nephrolithiasis is extremely high and may range from 15 to 20 percent per year, with a cumulative incidence at five years ranging from 27 to 50 percent.Although genetic factors play an important role in the development of nephrolithiasis, environmental factors such as diet also appear to affect stone formation. Potassium citrate is also effective in preventing stone recurrence in patients with calcium oxalate nephrolithiasis. Low tolerability, however, may remarkably limit the use of these medication. Citrus fruits are a natural rich source of citrate and diet supplementation with juice of citrus fruits may represent a valuable alternative option to supply citrate without exposing the patients to the adverse effects of citrate containing medications. Among the most commonly consumed citrus fruits, lemons contain the greatest concentrations of citric acid (49,2 g/Kg);a half cup of pure lemon juice can provide a daily amount of citrate comparable to that of a standard daily dose of alkali citrate medications.

A few studies tried to evaluate the effects of lemon juice supplementation in patients with calcium oxalate nephrolithiasis, but the findings were flawed by the retrospective, observational design of the study or by the too small sample size that limited the power of statistical analyses and the reliability of the results. This study will be primarily aimed at evaluating whether lemon juice added to standard diet recommendations compared to diet recommendations alone may reduce the risk of new stone formation in patients with recurrent idiopathic calcium oxalate nephrolithiasis. Secondarily, the study will evaluate the effects of lemon juice supplementation on complications of nephrolithiasis such as urinary tract infections, colic symptoms, and hospitalizations for stone disruption or removal, as well as the effects on urinary factors (such as urinary citrate, oxalate, calcium excretion or pH) that may favor or limit stone formations and the relationships between these effects and the risk of stone recurrence.


Condition Intervention Phase
Nephrolithiasis
Dietary Supplement: Lemon supplementation
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Prospective, Randomized, Open Blind Endpoint (Probe) Trial to Assess the Possibility to Prevent Stone Recurrence by Lemon Juice Supplementation in Patients With Recurrent Calcium Oxalate Nephrolithiasis (LIMONE Study)

Resource links provided by NLM:


Further study details as provided by Mario Negri Institute for Pharmacological Research:

Primary Outcome Measures:
  • Spontaneous passage of stone or gravel. [ Time Frame: At 6 month. ] [ Designated as safety issue: No ]
  • Appearance of new stones. [ Time Frame: At 6 month. ] [ Designated as safety issue: No ]
  • More than 30 percent increase in pre-existing stone size [ Time Frame: At 6 month. ] [ Designated as safety issue: No ]
  • Spontaneous passage of stone or gravel. [ Time Frame: At 12 month. ] [ Designated as safety issue: No ]
  • Spontaneous passage of stone or gravel. [ Time Frame: At 24 month. ] [ Designated as safety issue: No ]
  • Appearance of new stones. [ Time Frame: At 12 month. ] [ Designated as safety issue: No ]
  • Appearance of new stones. [ Time Frame: At 24 month. ] [ Designated as safety issue: No ]
  • More than 30 percent increase in pre-existing stone size [ Time Frame: At 12 month. ] [ Designated as safety issue: No ]
  • More than 30 percent increase in pre-existing stone size [ Time Frame: At 24 month. ] [ Designated as safety issue: No ]

Estimated Enrollment: 202
Study Start Date: January 2009
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lemon supplementation YES
60 ml of lemon juice twice daily (an amount expected to provide 6 grams or 92 mEq of citric acid per day)
Dietary Supplement: Lemon supplementation
60 ml of lemon juice twice daily (an amount expected to provide 6 grams or 92 mEq of citric acid per day)
No Intervention: Lemon supplementation NO
No lemon supplementation

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • male and female >18 years
  • history of recurrent nephrolithiasis, with one o more calcium oxalate or mixed (calcium oxalate and phosphate, calcium oxalate and uric acid) stone formation over the last 5 years
  • at least one kidney stone at baseline documented by renal echography and/or X-ray evaluation.
  • written informed consent

Exclusion Criteria:

  • Obstructive uropathy, chronic urosepsis, renal failure (serum creatinine >1.8 mg/dl), renal tubular acidosis, primary hyperparathyroidism, primary hyperoxaluria, pure uric acid and cystine stones, medullary sponge kidney
  • lithotripsy treatment within the last 6 months
  • active peptic ulcer disease, gastric esophagus reflux
  • concomitant clinical conditions that might affect completion of the study or jeopardize data interpretation
  • pharmacological therapy for stone disease over the last month
  • impossibility to assess the number of kidney stones
  • inability to provide an informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01217372

Contacts
Contact: Piero Ruggenenti, MD 0039 035 45351 piero.ruggenenti@marionegri.it

Locations
Italy
Unit of Nephrology and Dialysis Recruiting
Bergamo, Italy, 24128
Contact: Piero Ruggenenti, MD    003903545351    piero.ruggenenti@marionegri.it   
Sub-Investigator: Mariarosa Caruso, MD         
Sponsors and Collaborators
Mario Negri Institute for Pharmacological Research
  More Information

No publications provided

Responsible Party: Mario Negri Institute for Pharmacological Research
ClinicalTrials.gov Identifier: NCT01217372     History of Changes
Other Study ID Numbers: LIMONE
Study First Received: September 30, 2010
Last Updated: September 17, 2014
Health Authority: Italy: Ministry of Health

Keywords provided by Mario Negri Institute for Pharmacological Research:
Recurrent idiopathic calcium oxalate nephrolithiasis.

Additional relevant MeSH terms:
Nephrolithiasis
Kidney Diseases
Urologic Diseases
Urolithiasis

ClinicalTrials.gov processed this record on September 18, 2014