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CompletedNCT06681116Updated Nov 8, 2024

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

An interventional study of structured nano-water and Hydrochlorothiazide (HCTZ) in Renal Stones and Idiopathic Hypercalciuria, sponsored by ALI KAMAL M. SAMI. Completed at 1 site in Iraq. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-11-08.

Sponsored by ALI KAMAL M. SAMI · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 9 years 8 months after the study started (first participant enrolled Feb 2015, registered Nov 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
325
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Renal Stones
  • Idiopathic Hypercalciuria

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Keywords

  • recurrent renal stones
  • idiopathic hypercalciuria
  • nano-water
  • hydrochlorthiazide
03

In context

Nephrolithiasis

324 studies on the registry are indexed under Nephrolithiasis; 90 are open to participants now.

This study's enrollment of 325 is above the median of 92 across 257 interventional studies indexed under Nephrolithiasis.

Browse Nephrolithiasis studies →

Lead sponsor

ALI KAMAL M. SAMI is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Idiopathic hypercalciuria
  • history of previous renal stones

Exclusion criteria

Exclusion Criteria:

  • already present renal stones
  • previous surgery of the kidneys
  • Congenital anomalies of the urinary system
  • Renal failure
  • Allergy to hydrochlorothiazide
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
325 participants (actual)

Study arms

  • Experimental
    Patients with idiopathic hypercalciuria Group A

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

    Dietary Supplement: structured nano-water

  • Active comparator
    Patients with idiopathic hypercalciuria Group B

    Patients receiving Hydrochlorothiazide in a daily dose of 50 mg.

    Drug: Hydrochlorothiazide (HCTZ)

  • 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

Interventions

  • Dietary supplementstructured nano-water

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

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

  • Otherordinary bottled drinking water

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

06

What researchers measure

Primary outcomes

  1. Recurrent renal stones

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

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

07

Study locations

1 site
  • College of Medicine, University of Suliamani
    Sulaymaniyah, Kurdistan Region 46001, Iraq
08

References and documents

Individual participant data

Plan to share: No — Patients agreed to participate in this clinical trial based on keeping confidentiality about their personal informations

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06681116
Lead sponsor
ALI KAMAL M. SAMI
Responsible party
ALI KAMAL M. SAMI (Lecturer, College of Medicine,, University of Sulaimani) — Sponsor-investigator
First posted
Nov 8, 2024
Start date
Feb 16, 2015
Primary completion
Aug 24, 2020
Completion
Aug 24, 2020
Last update
Nov 8, 2024

Study contacts

Ali K M. Sami, MBChB FIBMS
principal investigator · College of Medicine, University of Sulaimani

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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