Clinical Trial: Nephrolithiasis Prevention by Lemon Juice

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

Brief Summary:

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 idiopathi

Detailed Summary:

BACKGROUND 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. Diet based on restricted intake of animal proteins and salt, combined with a normal calcium intake, may reduce the risk of stone formation. However, the efficacy in preventing stone recurrences is limited, in particular in repeated stone formers.

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), nearly 5 times the concentrations in the orange. 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. The citrate supplied with the juice that escapes metabolic degradation in vivo is excreted u
Sponsor: Mario Negri Institute for Pharmacological Research

Current Primary Outcome:

  • Spontaneous passage of stone or gravel. [ Time Frame: At 6 month. ]
  • Appearance of new stones. [ Time Frame: At 6 month. ]
  • More than 30 percent increase in pre-existing stone size [ Time Frame: At 6 month. ]
  • Spontaneous passage of stone or gravel. [ Time Frame: At 12 month. ]
  • Spontaneous passage of stone or gravel. [ Time Frame: At 24 month. ]
  • Appearance of new stones. [ Time Frame: At 12 month. ]
  • Appearance of new stones. [ Time Frame: At 24 month. ]
  • More than 30 percent increase in pre-existing stone size [ Time Frame: At 12 month. ]
  • More than 30 percent increase in pre-existing stone size [ Time Frame: At 24 month. ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Mario Negri Institute for Pharmacological Research

Dates:
Date Received: September 30, 2010
Date Started: January 2009
Date Completion: March 2019
Last Updated: January 11, 2017
Last Verified: January 2017