Nephrolithiasis Prevention by Lemon Juice

NCT01217372 | Completed Phase 2

• 1 other identifier: LIMONE
• Study Type: interventional
• Target: 203
• Locations: 1 country
• Sites: 1

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.

Conditions

Nephrolithiasis

Keywords

Recurrent idiopathic calcium oxalate nephrolithiasis.

Outcome Measures

Primary Outcomes (9)

• Spontaneous passage of stone or gravel.

  At 6 month.

• Appearance of new stones.

  At 6 month.

• More than 30 percent increase in pre-existing stone size

  At 6 month.

• Spontaneous passage of stone or gravel.

  At 12 month.

• Spontaneous passage of stone or gravel.

  At 24 month.

• Appearance of new stones.

  At 12 month.

• Appearance of new stones.

  At 24 month.

• More than 30 percent increase in pre-existing stone size

  At 12 month.

• More than 30 percent increase in pre-existing stone size

  At 24 month.

Study Arms (2)

Lemon supplementation YES

EXPERIMENTAL

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

Lemon supplementation NO

NO INTERVENTION

No lemon supplementation

Interventions

Lemon supplementation DIETARY_SUPPLEMENT

60 ml of lemon juice twice daily (an amount expected to provide 6 grams or 92 mEq of citric acid per day)

Lemon supplementation YES

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mario Negri Institute for Pharmacological Research: lead

Study Sites (1)

Unit of Nephrology and Dialysis

Bergamo, 24128, Italy

Location

MeSH Terms

Conditions

Nephrolithiasis

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2010
• First Posted: October 8, 2010
• Study Start: January 1, 2009
• Primary Completion: February 16, 2021
• Study Completion: February 16, 2021
• Last Updated: April 1, 2021

Record last verified: 2021-03

Locations

IT (1)