- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07715643
Vitamin E Supplementation Effect in Management of Calcium Oxalate Crystals
July 15, 2026 updated by: Maria Aslam, University of Lahore
Comparative Effect of Different Concentrations of Vitamin E Supplementation in Management of Calcium Oxalate Crystals in Nephrolithiatic Patients
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Lahore, Pakistan
- The University of Lahore
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control Group T0
The control group (T0) did not receive any additional treatment except routine medications
|
The participants were on conventional medicines
|
|
Experimental: Intervention Group T1
T1 group participants were taking 200mg/day of Vitamin E along with conventional medicines
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T1 group participants were taking 200mg/day of Vitamin E supplementation once a day along with conventional medicines
|
|
Experimental: Intervention Group T2
T2 group participants were taking 400mg/day of Vitamin E along with conventional medicines
|
T2 group participants were taking 400mg/day of Vitamin E supplementation once a day along with conventional medicines
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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8 weeks
|
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Renal function test
Time Frame: 8 weeks
|
This involved measuring the levels of BUN (blood urea nitrogen) and creatinine in the blood.
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8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 5, 2022
Primary Completion (Actual)
February 7, 2023
Study Completion (Actual)
April 5, 2023
Study Registration Dates
First Submitted
July 15, 2026
First Submitted That Met QC Criteria
July 15, 2026
First Posted (Actual)
July 20, 2026
Study Record Updates
Last Update Posted (Actual)
July 20, 2026
Last Update Submitted That Met QC Criteria
July 15, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-UOL-FAHS/951/2022
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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