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.

Study Overview

• Status: Completed
• Conditions: Renal Stones; Idiopathic Hypercalciuria
• Intervention / Treatment: Dietary supplement: structured nano-water; Drug: Hydrochlorothiazide (HCTZ); Other: ordinary bottled drinking water

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.

• Study Type: Interventional
• Enrollment (Actual): 325
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iraq
  • Kurdistan Region
    • Sulaymaniyah, Kurdistan Region, Iraq, 46001
      • College of Medicine, University of Suliamani

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with idiopathic hypercalciuria Group A; Patients receiving nano-water in a daily dose of 20 mL/Kg	Dietary supplement: structured nano-water; Hydrochlorothiazide is a drug used to prevent recurrent renal stone formation in patients with idiopathic hypercalciuria
Active Comparator: Patients with idiopathic hypercalciuria Group B; Patients receiving Hydrochlorothiazide in a daily dose of 50 mg.	Drug: Hydrochlorothiazide (HCTZ); hydrochlorothiazide is a drug used to prevent recurrent stone formation i patients with idiopathic hypercalciuria
Placebo Comparator: Patients with idiopathic hypercalciuria Group C; Patients receiving ordinary bottled drinking water in a daily dose of 20 mL/Kg	Other: ordinary bottled drinking water; Patients with idiopathic hypercalciuria receiving regular bottled drinking water as a placebo to see its effect.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrent renal stones	recurrent renal stone were diagnosed by ultrasound and X-ray ( kidney ureter Bladder X-ray)	From enrollment to the end of treatment at 36 months

Collaborators and Investigators

• Sponsor: ALI KAMAL M. SAMI
• Investigators: Principal Investigator: Ali K M. Sami, MBChB FIBMS, College of Medicine, University of Sulaimani

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2015
• Primary Completion (Actual): August 24, 2020
• Study Completion (Actual): August 24, 2020

Study Registration Dates

• First Submitted: November 7, 2024
• First Submitted That Met QC Criteria: November 7, 2024
• First Posted (Estimated): November 8, 2024

Study Record Updates

• Last Update Posted (Estimated): November 8, 2024
• Last Update Submitted That Met QC Criteria: November 7, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: recurrent renal stones; idiopathic hypercalciuria; nano-water; hydrochlorthiazide
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urolithiasis; Urinary Calculi; Urological Manifestations; Kidney Calculi; Nephrolithiasis; Hypercalciuria; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Diuretics; Natriuretic Agents; Antihypertensive Agents; Sodium Chloride Symporter Inhibitors; Hydrochlorothiazide
• Other Study ID Numbers: 173

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Patients agreed to participate in this clinical trial based on keeping confidentiality about their personal informations

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No