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Completed

NCT Number: NCT06681116

Use of Nanotechnology Structured Water for the Prevention of Recurrent Stone Formation

We assessed the effect of structured nano-water in the prevention of recurrent stone formation in patients with recurrent calcium oxalate stones and hypercalciuria.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

College of Medicine, University of Suliamani

Sulaymaniyah, Kurdistan Region, 46001, Iraq

About this study

The majority of stones (85%) contain primarily calcium oxalate. Most renal stones are idiopathic calcium stones, and the most common predisposing factor in these patients is hypercalciuria. Structured nano-water is a new type of water that has been prepared using different types of energy fields electromagnetic fields to produce this structured nano- water that has new and different characteristics from the ordinary water.

In this study, we compared the efficacy of the nano- water with hydrochlorothiazide and with ordinary bottled drinking water in the prevention of recurrent renal stones in patients with idiopathic hypercalciuria.

We conducted a three-year randomized trial comparing the effect of structured water with the effect of hydrochlorothiazide and ordinary bottled water in 325 patients with recurrent calcium oxalate stones and hypercalciuria.

The patients were randomly divided into three groups. Group A included 108 patients who used structured nano-water in a dose of 20 mL/kg as a daily dose.

Group B of 107 patients used 50 mg hydrochlorothiazide tablets as a daily dose, and group C consisted of another 110 patients used ordinary drinking bottled water in a daily dose of 20 mL/kg .

The assessments were done by urine analysis with renal ultrasonography and radiology ( Kidney Ureter Bladder KUB X-rays) were done at baseline, at yearly intervals, also at any time of recurrence, and at the end of the 3 years (36th month).

The patients, care providers, and the investigators were blinded about the type of water used since the water bottles were unlabeled when given to the patients.

All patients were informed and signed a written informed consent form.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Idiopathic hypercalciuria
  • history of previous renal stones

Exclusion criteria

  • already present renal stones
  • previous surgery of the kidneys
  • Congenital anomalies of the urinary system
  • Renal failure
  • Allergy to hydrochlorothiazide

Treatment and study plan

structured nano-water

Dietary Supplement

Hydrochlorothiazide is a drug used to prevent recurrent renal stone formation in patients with idiopathic hypercalciuria

Hydrochlorothiazide (HCTZ)

Drug

hydrochlorothiazide is a drug used to prevent recurrent stone formation i patients with idiopathic hypercalciuria

ordinary bottled drinking water

Other

Patients with idiopathic hypercalciuria receiving regular bottled drinking water as a placebo to see its effect.

Primary outcomes

  1. Recurrent renal stones

    Time frame: From enrollment to the end of treatment at 36 months

    recurrent renal stone were diagnosed by ultrasound and X-ray ( kidney ureter Bladder X-ray)

Sponsors and collaborators

Lead sponsor

ALI KAMAL M. SAMI

Other

Registry information

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Nov 8, 2024
Registry last updated
Nov 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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