NephrolithiasisNCT07715643
Vitamin E Supplementation Effect in Management of Calcium Oxalate Crystals
A study testing Intervention Group T1 and Intervention Group T2 in people with Nephrolithiasis and Calcium Oxalate Kidney Stones, run by University of Lahore at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Nephrolithiasis, Calcium Oxalate Kidney Stones
- What is being tested?
- Intervention Group T1 and Intervention Group T2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 sitePakistan
- Study dates
- 5 Dec 2022to 5 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Nephrolithiasis, Calcium Oxalate Kidney Stones
- Being tested
- Control Group T0, Intervention Group T1, Intervention Group T2
- Keywords
- Nephrolithiasis, Calcium Oxalate Kidney Stones, Body Mass Index
- Medical subject headings
- Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control Group T0Drug
The participants were on conventional medicines
Intervention Group T1Dietary supplement
T1 group participants were taking 200mg/day of Vitamin E supplementation once a day along with conventional medicines
Intervention Group T2Dietary supplement
T2 group participants were taking 400mg/day of Vitamin E supplementation once a day along with conventional medicines
| Study group | Role | What they receive |
|---|---|---|
| Control Group T0 | Active comparator | The control group (T0) did not receive any additional treatment except routine medications Receives: Drug: Control Group T0 |
| Intervention Group T1 | Experimental | T1 group participants were taking 200mg/day of Vitamin E along with conventional medicines Receives: Dietary Supplement: Intervention Group T1 |
| Intervention Group T2 | Experimental | T2 group participants were taking 400mg/day of Vitamin E along with conventional medicines Receives: Dietary Supplement: Intervention Group T2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Renal function test
This involved measuring the levels of BUN (blood urea nitrogen) and creatinine in the blood.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start5 Dec 2022
- Primary completion7 Feb 2023
- Study completion5 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NephrolithiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Aslam, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07715643
- Sponsor's protocol ID
- IRB-UOL-FAHS/951/2022
- Status last verified
- Jul 2026
- First submitted
- 15 Jul 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effect of Different Concentrations of Vitamin E Supplementation in Management of Calcium Oxalate Crystals in Nephrolithiatic Patients
- ClinicalTrials.gov ID
- NCT07715643
- Acronym / sponsor ID
- IRB-UOL-FAHS/951/2022
- Conditions
- Nephrolithiasis, Calcium Oxalate Kidney Stones
- Keywords
- Nephrolithiasis, Calcium Oxalate Kidney Stones, Body Mass Index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 5 Dec 2022 (actual)
- Primary completion
- 7 Feb 2023 (actual)
- Study completion
- 5 Apr 2023 (actual)
- First posted
- 20 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group T0 | Active comparator | Drug: Control Group T0The control group (T0) did not receive any additional treatment except routine medications |
| Intervention Group T1 | Experimental | Dietary Supplement: Intervention Group T1T1 group participants were taking 200mg/day of Vitamin E along with conventional medicines |
| Intervention Group T2 | Experimental | Dietary Supplement: Intervention Group T2T2 group participants were taking 400mg/day of Vitamin E along with conventional medicines |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control Group T0The participants were on conventional medicines | Drug | Control Group T0 |
| Intervention Group T1T1 group participants were taking 200mg/day of Vitamin E supplementation once a day along with conventional medicines | Dietary supplement | Intervention Group T1 |
| Intervention Group T2T2 group participants were taking 400mg/day of Vitamin E supplementation once a day along with conventional medicines | Dietary supplement | Intervention Group T2 |
Primary outcome
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.
Renal function test
Time frame: 8 weeks
This involved measuring the levels of BUN (blood urea nitrogen) and creatinine in the blood.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Group T1 and Intervention Group T2 in people with Nephrolithiasis and Calcium Oxalate Kidney Stones, run by University of Lahore at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urine Analysis (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.