Nephrolithiasis Prevention by Lemon Juice (LIMONE)
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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) |
- 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 2014 |
| Estimated Primary Completion Date: | December 2013 (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 |
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| Contact: Piero Ruggenenti, MD | 0039 035 45351 | piero.ruggenenti@marionegri.it |
| Italy | |
| Unit of Nephrology and Dialysis | Recruiting |
| Bergamo, Italy, 24128 | |
| Contact: Piero Ruggenenti, MD 003903545351 piero.ruggenenti@marionegri.it | |
| Sub-Investigator: Mariarosa Caruso, MD | |
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: | February 22, 2013 |
| 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 June 17, 2013