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Mineral Water for Prevention of Renal Stones

Primary Purpose

Calcium Oxalate Urolithiasis

Status
Unknown status
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Mineral water
Plain water
Sponsored by
Singapore General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Calcium Oxalate Urolithiasis focused on measuring Mineral water, Disease prevention, 24h urine analysis

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients with proven Calcium Oxalate (CaOx) stone (CaOx >50% by infrared spectroscopy) from Jan 2018 to Aug 2019 in Singapore General Hospital
  • all stone formers had suffered spontaneous passage or surgical removal of a urinary calculus during the study period.

Exclusion Criteria:

  • presence of urinary tract infection
  • severe cardiovascular insufficiency
  • previously diagnosed causal metabolic disease such as hyperparathyroidism, renal tubular acidosis, primary hyperoxaluria, Wilson's disease, Cushing disease, osteoporosis and malignant diseases.
  • pregnant women
  • chronic intestinal diseases
  • history of previous bowel resection
  • participation in competitive sports

Sites / Locations

  • Singapore General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mineral water group

Plain water group

Arm Description

The mineral water group were instructed to consume 1.25L of a commercially supplied bicarbonate rich mineral water per day at meal times, supplemented by other fluid intake up to 2.5 - 3L/day.

The plain water group consumed only plain water up to 2.5 - 3L/day.

Outcomes

Primary Outcome Measures

changes of Tiselius Index
compare Tiselius Index (24h urine analysis) at week 1, 4, 8 and 12 to baseline (week 0)
changes of urinary oxalate level (mmol/24h)
compare urinary oxalate level (24h urine analysis) at week 1, 4, 8 and 12 to baseline (week 0)

Secondary Outcome Measures

changes of other stone inhibitor/promoter (mmol/24h)
compare Magnesium, Citrate, Sodium, Calcium, Uric Acid (24h urine analysis) at week 1, 4, 8 and 12 to baseline (week 0)
changes of urinary volume (ml/24h)
compare urinary volume (24h urine analysis) at week 1, 4, 8 and 12 to baseline (week 0)
changes of urinary pH
compare urinary pH (24h urine analysis) at week 1, 4, 8 and 12 to baseline (week 0)
changes of serum electrolytes (mmol/L)
compare serum sodium, potassium, calcium, phosphate, bicarbonate and uric acid at baseline (week 0) and the end of the study (week 12)

Full Information

First Posted
October 25, 2020
Last Updated
November 15, 2020
Sponsor
Singapore General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04638166
Brief Title
Mineral Water for Prevention of Renal Stones
Official Title
Mineral Water for Prevention of Renal Stones
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 25, 2018 (Actual)
Primary Completion Date
October 1, 2019 (Actual)
Study Completion Date
January 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Singapore General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The investigators would like to assess if the intake of high bicarbonate mineral water would not only increase total fluid intake but will also be able to give patients the additional benefit of correcting the urinary abnormalities which may predispose them to stone formation.
Detailed Description
The life time risk of developing nephrolithiasis is about 10-15% in the western world, but can be as high as 20-25% in the middle east. Evidence suggests that the incidence and prevalence of kidney stones is increasing globally which represent a significant economic burden. Besides the lack of hydration, the most common metabolic abnormalities associated with calcium stones are hypercalciuria, hypocitraturia and hyperoxaluria. In addition, low urinary pH from consumption of non-dairy animal protein has been associated with reduced urinary citrate and increased uric acid stones which form a nidus for subsequent calcium oxalate precipitates. Dietary modification is the first line approach in the treatment of idiopathic calcium oxalate (CaOx) nephrolithiasis. General advice includes adequate hydration, avoiding oxalate-rich foods, and consumption of an adequate amount of calcium. Adequate hydration is an easy and effective way of preventing stones. Siener et al found in healthy men, consumption of mineral water rich in magnesium and bicarbonate resulted in favourable changes in urinary pH, magnesium and citrate excretion (inhibitors of CaOx stone formation). Our pilot study in 10 young and healthy surgical residents also revealed similar results after drinking bicarbonate rich mineral water for 1 week. In this study, the investigators compared the effect of drinking bicarbonate rich mineral water with plain water on urine biochemistry in a prospective randomized study in patients with known CaOx stones. The investigators hypothesize that the intake of bicarbonate rich mineral water, particularly at meal times, reduces stone risk via reduction in urinary oxalate through increased intestinal oxalate binding with dietary calcium. Other potential benefits of mineral water include increased urinary stone inhibitors like magnesium, citrate and alkalinisation of urine.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Calcium Oxalate Urolithiasis
Keywords
Mineral water, Disease prevention, 24h urine analysis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mineral water group
Arm Type
Experimental
Arm Description
The mineral water group were instructed to consume 1.25L of a commercially supplied bicarbonate rich mineral water per day at meal times, supplemented by other fluid intake up to 2.5 - 3L/day.
Arm Title
Plain water group
Arm Type
Active Comparator
Arm Description
The plain water group consumed only plain water up to 2.5 - 3L/day.
Intervention Type
Other
Intervention Name(s)
Mineral water
Intervention Description
Drinking mineral water for 12 weeks
Intervention Type
Other
Intervention Name(s)
Plain water
Intervention Description
Drinking plain water for 12 weeks
Primary Outcome Measure Information:
Title
changes of Tiselius Index
Description
compare Tiselius Index (24h urine analysis) at week 1, 4, 8 and 12 to baseline (week 0)
Time Frame
1, 4, 8 and 12 weeks
Title
changes of urinary oxalate level (mmol/24h)
Description
compare urinary oxalate level (24h urine analysis) at week 1, 4, 8 and 12 to baseline (week 0)
Time Frame
1, 4, 8 and 12 weeks
Secondary Outcome Measure Information:
Title
changes of other stone inhibitor/promoter (mmol/24h)
Description
compare Magnesium, Citrate, Sodium, Calcium, Uric Acid (24h urine analysis) at week 1, 4, 8 and 12 to baseline (week 0)
Time Frame
1, 4, 8 and 12 weeks
Title
changes of urinary volume (ml/24h)
Description
compare urinary volume (24h urine analysis) at week 1, 4, 8 and 12 to baseline (week 0)
Time Frame
1, 4, 8 and 12 weeks
Title
changes of urinary pH
Description
compare urinary pH (24h urine analysis) at week 1, 4, 8 and 12 to baseline (week 0)
Time Frame
1, 4, 8 and 12 weeks
Title
changes of serum electrolytes (mmol/L)
Description
compare serum sodium, potassium, calcium, phosphate, bicarbonate and uric acid at baseline (week 0) and the end of the study (week 12)
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients with proven Calcium Oxalate (CaOx) stone (CaOx >50% by infrared spectroscopy) from Jan 2018 to Aug 2019 in Singapore General Hospital all stone formers had suffered spontaneous passage or surgical removal of a urinary calculus during the study period. Exclusion Criteria: presence of urinary tract infection severe cardiovascular insufficiency previously diagnosed causal metabolic disease such as hyperparathyroidism, renal tubular acidosis, primary hyperoxaluria, Wilson's disease, Cushing disease, osteoporosis and malignant diseases. pregnant women chronic intestinal diseases history of previous bowel resection participation in competitive sports
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tsung Wen Chong, MBBS, PhD
Organizational Affiliation
Singapore General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Singapore General Hospital
City
Singapore
Country
Singapore

12. IPD Sharing Statement

Plan to Share IPD
No

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Mineral Water for Prevention of Renal Stones

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