NCT07715643

Brief Summary

Nephrolithiasis is a condition characterized by the formation of crystalline stones in the urinary system. The most common component of these stones is calcium oxalate. The current study was proposed to explore the effect of different concentration of vitamin E supplementation on Calcium oxalate crystal among nephrolithiatic patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 5, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2023

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

July 15, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 20, 2026

Completed
Last Updated

July 20, 2026

Status Verified

July 1, 2026

Enrollment Period

2 months

First QC Date

July 15, 2026

Last Update Submit

July 15, 2026

Conditions

NephrolithiasisCalcium Oxalate Kidney Stones

Keywords

NephrolithiasisCalcium Oxalate Kidney StonesBody Mass Index

Outcome Measures

Primary Outcomes (2)

  • Urine Analysis

    The laboratory reading of urine analysis involves the identification and microscopic examination of urine to assess the characteristics and concentration of calcium and oxalate crystals present.

    8 weeks

  • Renal function test

    This involved measuring the levels of BUN (blood urea nitrogen) and creatinine in the blood.

    8 weeks

Study Arms (3)

Control Group T0

ACTIVE COMPARATOR

The control group (T0) did not receive any additional treatment except routine medications

Drug: Control Group T0

Intervention Group T1

EXPERIMENTAL

T1 group participants were taking 200mg/day of Vitamin E along with conventional medicines

Dietary Supplement: Intervention Group T1

Intervention Group T2

EXPERIMENTAL

T2 group participants were taking 400mg/day of Vitamin E along with conventional medicines

Dietary Supplement: Intervention Group T2

Interventions

Control Group T0DRUG

The participants were on conventional medicines

Control Group T0
Intervention Group T1DIETARY_SUPPLEMENT

T1 group participants were taking 200mg/day of Vitamin E supplementation once a day along with conventional medicines

Intervention Group T1
Intervention Group T2DIETARY_SUPPLEMENT

T2 group participants were taking 400mg/day of Vitamin E supplementation once a day along with conventional medicines

Intervention Group T2

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Both male and female.
  • Participants between the age of 20-50 years old.
  • Presence of calcium oxalate crystals in urine and kidneys
  • The size of the stones will range from 2 to 5 mm.

You may not qualify if:

  • People having stones of Uric acid, struvite, Cystine.
  • People having any other medical condition (End stage renal disease, Chronic Kidney disease, Kidney failure, and dialysis) .
  • Subjects were excluded if they were taking any medications, which might affect vitamin E metabolism (such as Wrafrin, dalteparin sodium, enoxaparin sodium).
  • Pregnant and lactating females.
  • People having known allergies to Vitamin E supplementation (rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing).
  • Participants enrolled in other studies or taking other nutraceutical preparations.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Lahore

Lahore, Pakistan

Location

Related Links

MeSH Terms

Conditions

Nephrolithiasis

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Head

Study Record Dates

First Submitted

July 15, 2026

First Posted

July 20, 2026

Study Start

December 5, 2022

Primary Completion

February 7, 2023

Study Completion

April 5, 2023

Last Updated

July 20, 2026

Record last verified: 2026-07

Locations

PA(1)