Clinical trial NCT06681116: Use of Nanotechnology Structured Water for the Prevention of Recurrent Stone Formation
Official title: Use of Nanotechnology Structured Water for the Prevention of Recurrent Stone Formation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Stones
Idiopathic Hypercalciuria
Keywords: recurrent renal stones
idiopathic hypercalciuria
nano-water
hydrochlorthiazide
Lead sponsor: University of Sulaimani
Sponsor class: OTHER
First posted: 2024-11-08
Enrollment: 325
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three groups that run parallel and receive the different allocated modalities and are followed up for three consecutive years
Primary purpose: PREVENTION

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Recurrent renal stones
timeFrame: From enrollment to the end of treatment at 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sulaymaniyah
country: Iraq
facility: College of Medicine, University of Suliamani
state: Kurdistan Region
Study officials:
affiliation: College of Medicine, University of Sulaimani
name: Ali K M. Sami, MBChB FIBMS
role: PRINCIPAL_INVESTIGATOR
References: