NCT04638166

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 25, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 25, 2020

Completed
26 days until next milestone

First Posted

Study publicly available on registry

November 20, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

November 20, 2020

Status Verified

November 1, 2020

Enrollment Period

1.7 years

First QC Date

October 25, 2020

Last Update Submit

November 15, 2020

Conditions

Calcium Oxalate Urolithiasis

Keywords

Mineral waterDisease prevention24h urine analysis

Outcome Measures

Primary Outcomes (2)

  • changes of Tiselius Index

    compare Tiselius Index (24h urine analysis) at week 1, 4, 8 and 12 to baseline (week 0)

    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)

    1, 4, 8 and 12 weeks

Secondary Outcomes (4)

  • changes of other stone inhibitor/promoter (mmol/24h)

    1, 4, 8 and 12 weeks

  • changes of urinary volume (ml/24h)

    1, 4, 8 and 12 weeks

  • changes of urinary pH

    1, 4, 8 and 12 weeks

  • changes of serum electrolytes (mmol/L)

    12 weeks

Study Arms (2)

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.

Other: Mineral water

Plain water group

ACTIVE COMPARATOR

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

Other: Plain water

Interventions

Mineral waterOTHER

Drinking mineral water for 12 weeks

Mineral water group
Plain waterOTHER

Drinking plain water for 12 weeks

Plain water group

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Singapore General Hospital

Singapore, Singapore

Location

MeSH Terms

Conditions

Nephrolithiasis, Calcium Oxalate

Interventions

Mineral Waters

Intervention Hierarchy (Ancestors)

WaterHydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Officials

  • Tsung Wen Chong, MBBS, PhD

    Singapore General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2020

First Posted

November 20, 2020

Study Start

January 25, 2018

Primary Completion

October 1, 2019

Study Completion

January 1, 2021

Last Updated

November 20, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)