Mineral Water for Prevention of Renal Stones

NCT ID: NCT04638166

Last Updated: 2020-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-25

Study Completion Date

2021-01-31

Brief Summary

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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

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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.

Conditions

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Calcium Oxalate Urolithiasis

Keywords

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Mineral water Disease prevention 24h urine analysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Mineral water group

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.

Group Type EXPERIMENTAL

Mineral water

Intervention Type OTHER

Drinking mineral water for 12 weeks

Plain water group

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

Group Type ACTIVE_COMPARATOR

Plain water

Intervention Type OTHER

Drinking plain water for 12 weeks

Interventions

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Mineral water

Drinking mineral water for 12 weeks

Intervention Type OTHER

Plain water

Drinking plain water for 12 weeks

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Singapore General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tsung Wen Chong, MBBS, PhD

Role: PRINCIPAL_INVESTIGATOR

Singapore General Hospital

Locations

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Singapore General Hospital

Singapore, , Singapore

Site Status

Countries

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Singapore

Other Identifiers

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MINERVA

Identifier Type: -

Identifier Source: org_study_id