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

NCT ID: NCT06681116

Last Updated: 2024-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

325 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-16

Study Completion Date

2020-08-24

Brief Summary

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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

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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.

Conditions

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Renal Stones Idiopathic Hypercalciuria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Three groups that run parallel and receive the different allocated modalities and are followed up for three consecutive years
Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
neither the participants nor the investigators or the care givers and the outcome assessors knew the group of patients

Study Groups

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Patients with idiopathic hypercalciuria Group A

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

Group Type EXPERIMENTAL

structured nano-water

Intervention Type DIETARY_SUPPLEMENT

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

Patients with idiopathic hypercalciuria Group B

Patients receiving Hydrochlorothiazide in a daily dose of 50 mg.

Group Type ACTIVE_COMPARATOR

Hydrochlorothiazide (HCTZ)

Intervention Type DRUG

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

Patients with idiopathic hypercalciuria Group C

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

Group Type PLACEBO_COMPARATOR

ordinary bottled drinking water

Intervention Type OTHER

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

Interventions

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structured nano-water

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

Intervention Type DIETARY_SUPPLEMENT

Hydrochlorothiazide (HCTZ)

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

Intervention Type DRUG

ordinary bottled drinking water

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ALI KAMAL M. SAMI

OTHER

Sponsor Role lead

Responsible Party

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ALI KAMAL M. SAMI

Lecturer, College of Medicine,

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Ali K M. Sami, MBChB FIBMS

Role: PRINCIPAL_INVESTIGATOR

College of Medicine, University of Sulaimani

Locations

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College of Medicine, University of Suliamani

Sulaymaniyah, Kurdistan Region, Iraq

Site Status

Countries

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Iraq

Other Identifiers

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173

Identifier Type: -

Identifier Source: org_study_id

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