An interventional study of Mineral water and Plain water in Calcium Oxalate Urolithiasis, sponsored by Singapore General Hospital. Status unknown at 1 site in Singapore. Open to participants aged 21 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-11-20.
Sponsored by Singapore General Hospital · Not applicable, Interventional, and Prevention
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.
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.
278 studies on the registry are indexed under Urolithiasis; 70 are open to participants now.
This study's enrollment of 58 is below the median of 100 across 197 interventional studies indexed under Urolithiasis.
Browse Urolithiasis studies →Singapore General Hospital is the lead sponsor of 266 studies on the registry; 57 are open to participants now.
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Exclusion Criteria:
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
The plain water group consumed only plain water up to 2.5 - 3L/day.
Other: Plain water
Drinking mineral water for 12 weeks
Drinking plain water for 12 weeks
changes of Tiselius Index
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
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)
Time frame: 1, 4, 8 and 12 weeks
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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 12 weeks
Plan to share: No
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This study is status unknown, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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Singapore General Hospital