UrolithiasisNCT04571359
Spot Urine Oxalate to Creatinine Ratio and 24 Hours Urinary Oxalate
An observational study of Urolithiasis and Hyperoxaluria, run by Aga Khan University at 1 site in Pakistan.
Trial summary
The evaluation of 24 hour urinary oxalate excretion is the gold standard for diagnosing Hyperoxaluria in patients with recurrent urolithiasis. The relationship of oxalate measurement between spot and 24 hour urine sample has not been studied in Pakistani population before. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Urolithiasis, Hyperoxaluria
- What is being tested?
- Oxalate to creatinine ratio
- How many people
- 62 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Feb 2019to 31 Dec 2019
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Adult patients with history of kidney stones presenting at the Clinical Laboratory for 24 hours urine oxalate estimation.
Who may be able to join
- Patients with history of kidney stones.
- All patients investigated for 24 hour urinary oxalate excretion.
- Patients between 18 years to 60 years would be included.
- Both genders will be included.
Who cannot join
- Debilitated patients or bed ridden patients in whom proper and complete 24 hour urine collection will be troublesome.
- Patients with renal failure/end stage renal disease, in whom urinary oxalate is no longer an indicator of disease status.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relationship of Spot Urine Oxalate to Creatinine Ratio and 24 Hours Urinary Oxalate Excretion in Patients With Urolithiasis
The evaluation of 24 hour urinary oxalate excretion is the gold standard for diagnosing Hyperoxaluria in patients with recurrent urolithiasis. The relationship of oxalate measurement between spot and 24 hour urine sample has not been studied in Pakistani population before. Thus, it is necessary to see if spot urine samples show good correlation with 24 hour urine samples in our population where the frequency of hyperoxaluria in patients with urolithiasis is reported to be 64.5%. Also, the various pre analytical issues associated with 24 hour urinary collection which may lead to the incorrect or misdiagnosis, need for duplicate testing consuming extra resources and man power. We therefore, in this study, want to see the correlation between 24 hour urinary oxalate and oxalate to creatinine ratio. The aim of our study is to determine the relationship between 24 hour urinary oxalate and spot urine oxalate to creatinine ratio and to identify if oxalate to creatinine ratio can be used as an alternative to 24 hour urinary oxalate
Read the detailed description
A cross-sectional study was conducted at Section of Chemical Pathology, Department of Pathology and Laboratory Medicine, Aga Khan University, Karachi from 1st February to 31st December 2019. Adult patients with history of kidney stones presenting at the Clinical Laboratory for 24 hours urine oxalate estimation were included in the study. Debilitated or bed ridden patients and patients with renal failure or end stage renal disease, in whom urinary oxalate is no longer an indicator of disease status were excluded from the study. Study was approved by ethical review committee of Aga Khan University Hospital. Patients after informed consent, were guided to submit a spot urine sample. Clinical details were recorded on a structured questionnaire by the principal investigator.
24 hour urine samples were collected in a jar having thymol, which is routinely added to limit bacterial growth and hence guard against citrate degradation. Spot urine samples were collected in red top container without any added preservatives. The specimen were transported to the laboratory within the 12 hours of collection of 24 hour urinary specimen.
Volume of 24 hour urine was measured in liters. After mixing of the urinary sample to overcome effects of sedimentation, a 6 ml aliquot was made and HCl was added to avoid the precipitation of oxalate crystals in every sample. Specimen was stored at -20 C till further analysis.
Urinary oxalate was measured on Micro lab 300 using a kit based on oxalate oxidase principle by Trinity Biotech plc. Wick low, Ireland following standard operating procedures. Urinary creatinine was measured on ADVIA 1800 by Siemens, US using kinetic Jaffe reaction. Both normal and abnormal quality control materials were run with every batch of oxalate and creatinine analysis in urine to validate the results. In addition, external proficiency testing of urinary oxalate was conducted by College of American Pathologists (CAP).
The cut-offs for 24 hour oxalate excretion was 502 ųmol/24 hours for males and 353 ųmol/24 hours for females. The cut-offs for spot oxalate: creatinine ratio was 33 ųmol/mmol for males and 45 ųmol/mmol for females.
- Conditions
- Urolithiasis, Hyperoxaluria
- Being tested
- Oxalate to creatinine ratio
- Keywords
- 24-hour urinary oxalate, Spot oxalate to creatinine ratio
- Medical subject headings
- Urolithiasis, Hyperoxaluria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxalate to creatinine ratioOther
Comparsion between 24 hours urine oxalate and spot urine oxalate to creatinine ratio
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship between 24 hour urinary oxalate excretion and spot urine oxalate to creatinine ratio
Relationship between 24 hour urinary oxalate excretion and spot urine oxalate to creatinine ratio to determine its clinical utility against the use of 24 hour urinary oxalate estimation which is the standard practice.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2020
- Study start1 Feb 2019
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for UrolithiasisStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 62 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Syed bilal hashmi, Aga Khan University
- Investigators
- Syed bilal hashmi, Principal investigator, AKUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04571359
- Sponsor's protocol ID
- 5084-Pat-ERC-17
- Status last verified
- Sep 2020
- First submitted
- 27 Sep 2020
- Last updated
- 1 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hagler L, Herman RH. Oxalate metabolism. I. Am J Clin Nutr. 1973 Jul;26(7):758-65. doi: 10.1093/ajcn/26.6.758. No abstract available.
PubMed 4576881Hoppe B. An update on primary hyperoxaluria. Nat Rev Nephrol. 2012 Jun 12;8(8):467-75. doi: 10.1038/nrneph.2012.113.
PubMed 22688746
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship of Spot Urine Oxalate to Creatinine Ratio and 24 Hours Urinary Oxalate Excretion in Patients With Urolithiasis
- ClinicalTrials.gov ID
- NCT04571359
- Acronym / sponsor ID
- 5084-Pat-ERC-17
- Conditions
- Urolithiasis, Hyperoxaluria
- Keywords
- 24-hour urinary oxalate, Spot oxalate to creatinine ratio
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 1 Oct 2020 (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.
The evaluation of 24 hour urinary oxalate excretion is the gold standard for diagnosing Hyperoxaluria in patients with recurrent urolithiasis. The relationship of oxalate measurement between spot and 24 hour urine sample has not been studied in Pakistani population before. Thus, it is necessary to see if spot urine samples show good correlation with 24 hour urine samples in our population where the frequency of hyperoxaluria in patients with urolithiasis is reported to be 64.5%. Also, the various pre analytical issues associated with 24 hour urinary collection which may lead to the incorrect or misdiagnosis, need for duplicate testing consuming extra resources and man power. We therefore, in this study, want to see the correlation between 24 hour urinary oxalate and oxalate to creatinine ratio. The aim of our study is to determine the relationship between 24 hour urinary oxalate and spot urine oxalate to creatinine ratio and to identify if oxalate to creatinine ratio can be used as an alternative to 24 hour urinary oxalate
Detailed description
A cross-sectional study was conducted at Section of Chemical Pathology, Department of Pathology and Laboratory Medicine, Aga Khan University, Karachi from 1st February to 31st December 2019. Adult patients with history of kidney stones presenting at the Clinical Laboratory for 24 hours urine oxalate estimation were included in the study. Debilitated or bed ridden patients and patients with renal failure or end stage renal disease, in whom urinary oxalate is no longer an indicator of disease status were excluded from the study. Study was approved by ethical review committee of Aga Khan University Hospital. Patients after informed consent, were guided to submit a spot urine sample. Clinical details were recorded on a structured questionnaire by the principal investigator.
24 hour urine samples were collected in a jar having thymol, which is routinely added to limit bacterial growth and hence guard against citrate degradation. Spot urine samples were collected in red top container without any added preservatives. The specimen were transported to the laboratory within the 12 hours of collection of 24 hour urinary specimen.
Volume of 24 hour urine was measured in liters. After mixing of the urinary sample to overcome effects of sedimentation, a 6 ml aliquot was made and HCl was added to avoid the precipitation of oxalate crystals in every sample. Specimen was stored at -20 C till further analysis.
Urinary oxalate was measured on Micro lab 300 using a kit based on oxalate oxidase principle by Trinity Biotech plc. Wick low, Ireland following standard operating procedures. Urinary creatinine was measured on ADVIA 1800 by Siemens, US using kinetic Jaffe reaction. Both normal and abnormal quality control materials were run with every batch of oxalate and creatinine analysis in urine to validate the results. In addition, external proficiency testing of urinary oxalate was conducted by College of American Pathologists (CAP).
The cut-offs for 24 hour oxalate excretion was 502 ųmol/24 hours for males and 353 ųmol/24 hours for females. The cut-offs for spot oxalate: creatinine ratio was 33 ųmol/mmol for males and 45 ųmol/mmol for females.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Adult patients with history of kidney stones presenting at the Clinical Laboratory for 24 hours urine oxalate estimation.
Key inclusion criteria (4 listed)
- Patients with history of kidney stones.
- All patients investigated for 24 hour urinary oxalate excretion.
- Patients between 18 years to 60 years would be included.
- Both genders will be included.
Key exclusion criteria (2 listed)
- Debilitated patients or bed ridden patients in whom proper and complete 24 hour urine collection will be troublesome.
- Patients with renal failure/end stage renal disease, in whom urinary oxalate is no longer an indicator of disease status.
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 |
|---|---|---|
| Oxalate to creatinine ratioComparsion between 24 hours urine oxalate and spot urine oxalate to creatinine ratio | Other | – |
Primary outcome
Relationship between 24 hour urinary oxalate excretion and spot urine oxalate to creatinine ratio
Time frame: 1 year
Relationship between 24 hour urinary oxalate excretion and spot urine oxalate to creatinine ratio to determine its clinical utility against the use of 24 hour urinary oxalate estimation which is the standard practice.
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 1 Oct 2020.
- Background: PubMed 4576881Hagler L, Herman RH. Oxalate metabolism. I. Am J Clin Nutr. 1973 Jul;26(7):758-65. doi: 10.1093/ajcn/26.6.758. No abstract available.
- Background: PubMed 22688746Hoppe B. An update on primary hyperoxaluria. Nat Rev Nephrol. 2012 Jun 12;8(8):467-75. doi: 10.1038/nrneph.2012.113.
- Individual participant dataSharing planned: Undecided
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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.
Syed bilal hashmi principal investigator
AKUH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urolithiasis and Hyperoxaluria, run by Aga Khan University 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 2 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 1 Oct 2020. 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?
Relationship between 24 hour urinary oxalate excretion and spot urine oxalate to creatinine ratio (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04571359, which also lists 2 linked publications.
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 1 Oct 2020; AzTrials last refreshed its copy on 8 Nov 2026.