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Completed

NCT Number: NCT07715643

Vitamin E Supplementation Effect in Management of Calcium Oxalate Crystals

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.

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Key information

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Lahore

Lahore, Pakistan

About this study

A randomized controlled trial (pre-post treatment) was conducted on 48 participants who met the inclusion criteria. The participants were selected from the OPD of Hussain Memorial Hospital in Lahore. They were divided into three groups, with each group consisting of 16 participants. The control group (T0) did not receive any treatment, while the treatment groups received different doses of Vitamin E supplementation. The first treatment group (T1) received 200mg of Vitamin E supplementation, and the second treatment group (T2) received 400mg of Vitamin E supplementation, both for a duration of 8 weeks. Data was collected at baseline and after the 8th week of the study, including blood samples for renal function tests (RFT), ultrasounds, and 24-hour urine samples for calcium and oxalate analysis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Control Group T0

Drug

The participants were on conventional medicines

Intervention Group T1

Dietary Supplement

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

Intervention Group T2

Dietary Supplement

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

Primary outcomes

  1. Urine Analysis

    Time frame: 8 weeks

    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.

  2. Renal function test

    Time frame: 8 weeks

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

Sponsors and collaborators

Lead sponsor

University of Lahore

Other

Registry information

Official study title

Comparative Effect of Different Concentrations of Vitamin E Supplementation in Management of Calcium Oxalate Crystals in Nephrolithiatic Patients

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 20, 2026
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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