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

NCT06681116 | Completed DMC

• 1 other identifier: 173
• Study Type: interventional
• Target: 325
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Stones; Idiopathic Hypercalciuria

Keywords

recurrent renal stones; idiopathic hypercalciuria; nano-water; hydrochlorthiazide

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Patients with idiopathic hypercalciuria Group A

EXPERIMENTAL

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

Dietary Supplement: structured nano-water

Patients with idiopathic hypercalciuria Group B

ACTIVE COMPARATOR

Patients receiving Hydrochlorothiazide in a daily dose of 50 mg.

Drug: Hydrochlorothiazide (HCTZ)

Patients with idiopathic hypercalciuria Group C

PLACEBO COMPARATOR

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

Other: ordinary bottled drinking water

Interventions

structured nano-water DIETARY_SUPPLEMENT

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

Patients with idiopathic hypercalciuria Group A

Hydrochlorothiazide (HCTZ) DRUG

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

Patients with idiopathic hypercalciuria Group B

ordinary bottled drinking water OTHER

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

Patients with idiopathic hypercalciuria Group C

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Idiopathic hypercalciuria
• history of previous renal stones

You may not qualify if:

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

Sponsors & Collaborators

• ALI KAMAL M. SAMI: lead

Study Sites (1)

College of Medicine, University of Suliamani

Sulaymaniyah, Kurdistan Region, 46001, Iraq

Location

MeSH Terms

Conditions

Nephrolithiasis

Interventions

Hydrochlorothiazide

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Ali K M. Sami, MBChB FIBMS

  College of Medicine, University of Sulaimani

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: neither the participants nor the investigators or the care givers and the outcome assessors knew the group of patients
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer, College of Medicine,

Model Details: Three groups that run parallel and receive the different allocated modalities and are followed up for three consecutive years

Study Record Dates

• First Submitted: November 7, 2024
• First Posted: November 8, 2024
• Study Start: February 16, 2015
• Primary Completion: August 24, 2020
• Study Completion: August 24, 2020
• Last Updated: November 8, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)