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Nephrolithiasis Prevention by Lemon Juice (LIMONE)

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ClinicalTrials.gov Identifier: NCT01217372
Recruitment Status : Active, not recruiting
First Posted : October 8, 2010
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):
Mario Negri Institute for Pharmacological Research

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 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 or disease Intervention/treatment Phase
Nephrolithiasis Dietary Supplement: Lemon supplementation Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 202 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Actual Study Start Date : January 2009
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Spontaneous passage of stone or gravel. [ Time Frame: At 6 month. ]
  2. Appearance of new stones. [ Time Frame: At 6 month. ]
  3. More than 30 percent increase in pre-existing stone size [ Time Frame: At 6 month. ]
  4. Spontaneous passage of stone or gravel. [ Time Frame: At 12 month. ]
  5. Spontaneous passage of stone or gravel. [ Time Frame: At 24 month. ]
  6. Appearance of new stones. [ Time Frame: At 12 month. ]
  7. Appearance of new stones. [ Time Frame: At 24 month. ]
  8. More than 30 percent increase in pre-existing stone size [ Time Frame: At 12 month. ]
  9. More than 30 percent increase in pre-existing stone size [ Time Frame: At 24 month. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

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): NCT01217372


Locations
Italy
Unit of Nephrology and Dialysis
Bergamo, Italy, 24128
Sponsors and Collaborators
Mario Negri Institute for Pharmacological Research

Responsible Party: Mario Negri Institute for Pharmacological Research
ClinicalTrials.gov Identifier: NCT01217372     History of Changes
Other Study ID Numbers: LIMONE
First Posted: October 8, 2010    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018

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

Additional relevant MeSH terms:
Nephrolithiasis
Kidney Calculi
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi
Calculi
Pathological Conditions, Anatomical