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临床试验/NCT04638166
NCT04638166Unknown不适用

Mineral Water for Prevention of Renal Stones

Singapore General Hospital1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2018年1月25日最近更新:
适应症

试验速览

阶段
不适用
入组人数
58
试验地点
1
主要终点
changes of Tiselius Index

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
21 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

changes of Tiselius Index

时间窗: 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)

时间窗: 1, 4, 8 and 12 weeks

compare urinary oxalate level (24h urine analysis) at week 1, 4, 8 and 12 to baseline (week 0)

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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Mineral Water for Prevention of Renal Stones | 临床试验