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

ALI KAMAL M. SAMI

Status: Completed

Conditions: Idiopathic Hypercalciuria; Renal Stones

Treatments: Drug: Hydrochlorothiazide (HCTZ); Dietary Supplement: structured nano-water; Other: ordinary bottled drinking water

Study type: Interventional

Funder types: Other

Identifiers

NCT06681116

173

Details and patient eligibility

About

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

Full 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.

Enrollment: 325 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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325 participants in 3 patient groups, including a placebo group

Patients with idiopathic hypercalciuria Group A

Experimental group

Description:

Patients receiving nano-water in a daily dose of 20 mL/Kg

Treatment:

Dietary Supplement: structured nano-water

Patients with idiopathic hypercalciuria Group B

Active Comparator group

Description:

Patients receiving Hydrochlorothiazide in a daily dose of 50 mg.

Treatment:

Drug: Hydrochlorothiazide (HCTZ)

Patients with idiopathic hypercalciuria Group C

Placebo Comparator group

Description:

Patients receiving ordinary bottled drinking water in a daily dose of 20 mL/Kg

Treatment:

Other: ordinary bottled drinking water