Calcium Oxalate UrolithiasisNCT04638166
Mineral Water for Prevention of Renal Stones
A study testing Mineral water and Plain water in people with Calcium Oxalate Urolithiasis, run by Singapore General Hospital at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Calcium Oxalate Urolithiasis
- What is being tested?
- Mineral water and Plain water
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteSingapore
- Study dates
- 25 Jan 2018to Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Calcium Oxalate Urolithiasis
- Being tested
- Mineral water, Plain water
- Keywords
- Mineral water, Disease prevention, 24h urine analysis
- Medical subject headings
- Nephrolithiasis, Calcium Oxalate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mineral waterOther
Drinking mineral water for 12 weeks
Plain waterOther
Drinking plain water for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Mineral water group | Experimental | 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. Receives: Other: Mineral water |
| Plain water group | Active comparator | The plain water group consumed only plain water up to 2.5 - 3L/day. Receives: Other: Plain water |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes of Tiselius Index
compare Tiselius Index (24h urine analysis) at week 1, 4, 8 and 12 to baseline (week 0)
Measured: 1, 4, 8 and 12 weeks
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)
Measured: 1, 4, 8 and 12 weeks
Secondary outcomes (4)
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)
Measured: 1, 4, 8 and 12 weeks
changes of urinary volume (ml/24h)
compare urinary volume (24h urine analysis) at week 1, 4, 8 and 12 to baseline (week 0)
Measured: 1, 4, 8 and 12 weeks
changes of urinary pH
compare urinary pH (24h urine analysis) at week 1, 4, 8 and 12 to baseline (week 0)
Measured: 1, 4, 8 and 12 weeks
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)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start25 Jan 2018
- Primary completion1 Oct 2019
- Study completionJan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Calcium Oxalate UrolithiasisStudies of the same condition, open and under way.
- More trials run by Singapore General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tsung Wen Chong, MBBS, PhD, Principal investigator, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04638166
- Sponsor's protocol ID
- MINERVA
- Status last verified
- Nov 2020
- First submitted
- 25 Oct 2020
- Last updated
- 20 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mineral Water for Prevention of Renal Stones
- ClinicalTrials.gov ID
- NCT04638166
- Acronym / sponsor ID
- MINERVA
- Conditions
- Calcium Oxalate Urolithiasis
- Keywords
- Mineral water, Disease prevention, 24h urine analysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Study start
- 25 Jan 2018 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- Jan 2021 (estimated)
- First posted
- 20 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mineral water group | Experimental | Other: Mineral waterThe 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. |
| Plain water group | Active comparator | Other: Plain waterThe plain water group consumed only plain water up to 2.5 - 3L/day. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mineral waterDrinking mineral water for 12 weeks | Other | Mineral water group |
| Plain waterDrinking plain water for 12 weeks | Other | Plain water group |
Primary outcome
changes of Tiselius Index
Time frame: 1, 4, 8 and 12 weeks
compare Tiselius Index (24h urine analysis) at week 1, 4, 8 and 12 to baseline (week 0)
changes of urinary oxalate level (mmol/24h)
Time frame: 1, 4, 8 and 12 weeks
compare urinary oxalate level (24h urine analysis) at week 1, 4, 8 and 12 to baseline (week 0)
4 secondary outcomes
changes of other stone inhibitor/promoter (mmol/24h)
Time frame: 1, 4, 8 and 12 weeks
changes of urinary volume (ml/24h)
Time frame: 1, 4, 8 and 12 weeks
changes of urinary pH
Time frame: 1, 4, 8 and 12 weeks
changes of serum electrolytes (mmol/L)
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tsung Wen Chong, MBBS, PhD principal investigator
Singapore General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mineral water and Plain water in people with Calcium Oxalate Urolithiasis, run by Singapore General Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes of Tiselius Index (time frame: 1, 4, 8 and 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2020.