NCT01005082

Brief Summary

Randomized clinical trial comparing water therapy plus low-salt diet to water therapy alone in patients affected by idiopathic calcium nephrolithiasis. Treatment duration: three months Primary end-point: correction of hypercalciuria Main inclusion criteria: calcium stone formers with idiopathic hypercalciuria, with at least one stone expelled and analyzed by infrared spectrophotometry; presence of hypercalciuria (\>300 mg/day in males and \>200 mg/day in females); 18-65 years. Main exclusion criteria: primary hyperparathyroidism, primary hyperoxaluria, enteric hyperoxaluria, bowel resection, inflammatory bowel disease, renal tubular acidosis, sarcoidosis, sponge kidney, hyperthyroidism, use of hypercalciuric drugs such as Vitamin D, acetazolamide, anti-epileptic drugs

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2005

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 29, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 30, 2009

Completed
Last Updated

October 30, 2009

Status Verified

October 1, 2009

Enrollment Period

3.7 years

First QC Date

October 29, 2009

Last Update Submit

October 29, 2009

Conditions

Hypercalciuria

Keywords

Low salt diet, idiopathic hypercalciuria, calcium stone formersCalcium stone formers with idiopathic hypercalciuria

Outcome Measures

Primary Outcomes (1)

  • Normalization of urinary calcium levels

Secondary Outcomes (1)

  • Change in urinary stone risk factors (e.g. urinary calcium, oxalate and sodium excretion); blood pressure reduction

Study Arms (2)

Low salt diet plus water therapy

EXPERIMENTAL
Behavioral: Low salt diet

water therapy alone

ACTIVE COMPARATOR
Behavioral: Water therapy alone

Interventions

Low salt dietBEHAVIORAL
Low salt diet plus water therapy
Water therapy aloneBEHAVIORAL
water therapy alone

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • idiopathic calcium stone formers, with at least one stone expelled and analyzed by infrared spectrophotometry; presence of hypercalciuria (\>300 mg/day in males and 20 mg/day in females);
  • years.

You may not qualify if:

  • primary hyperparathyroidism,
  • primary hyperoxaluria,
  • enteric hyperoxaluria,
  • bowel resection,
  • inflammatory bowel disease,
  • renal tubular acidosis,
  • sarcoidosis, sponge kidney,
  • hyperthyroidism,
  • use of hypercalciuric drugs such as Vitamin D,
  • acetazolamide,
  • anti-epileptic drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Parma, 43100, Italy

Location

Related Publications (2)

  • Borghi L, Schianchi T, Meschi T, Guerra A, Allegri F, Maggiore U, Novarini A. Comparison of two diets for the prevention of recurrent stones in idiopathic hypercalciuria. N Engl J Med. 2002 Jan 10;346(2):77-84. doi: 10.1056/NEJMoa010369.

    PMID: 11784873BACKGROUND

  • Nouvenne A, Meschi T, Prati B, Guerra A, Allegri F, Vezzoli G, Soldati L, Gambaro G, Maggiore U, Borghi L. Effects of a low-salt diet on idiopathic hypercalciuria in calcium-oxalate stone formers: a 3-mo randomized controlled trial. Am J Clin Nutr. 2010 Mar;91(3):565-70. doi: 10.3945/ajcn.2009.28614. Epub 2009 Dec 30.

    PMID: 20042524DERIVED

MeSH Terms

Conditions

Hypercalciuria

Interventions

Diet, Sodium-RestrictedWater

Condition Hierarchy (Ancestors)

Urological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaHydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 29, 2009

First Posted

October 30, 2009

Study Start

January 1, 2005

Primary Completion

September 1, 2008

Study Completion

December 1, 2008

Last Updated

October 30, 2009

Record last verified: 2009-10

Locations

IT(1)