HyperoxaluriaNCT04756024
Reference Interval of Spot Urinary Oxalate to Creatinine Ratio in Children
An observational study of Hyperoxaluria, run by Aga Khan University at 1 site in Pakistan.
Trial summary
Reference intervals (RI) of oxalate for the Pakistani population are not readily available. The values used by most labs are usually taken from the literature from studies mainly performed on Caucasian or from the manufacturer package insert of oxalate reagent kits [2]. Read more about this study
- Who is it for?
- Ages 15 days to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperoxaluria
- How many people
- 120 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jun 2018to 30 Oct 2019
- 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 15 days to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Healthy children less than 6 years of age (both genders)
Who may be able to join
- Inclusion criteria included children less than six years of age, not suffering from any illness during the last two weeks and no hospitalization since the last four weeks.
Who cannot join
- Children on vitamins or history of kidney stones or family history of kidney stones were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determination of Reference Interval of Spot Urinary Oxalate to Creatinine Ratio in Children of Pakistani Origin Under Six Years of Age
Reference intervals (RI) of oxalate for the Pakistani population are not readily available. The values used by most labs are usually taken from the literature from studies mainly performed on Caucasian or from the manufacturer package insert of oxalate reagent kits [2]. RI of an analyte assist the clinician in differentiating between health and disease [3]. It is established by testing healthy populations and figuring out what appears to be "normal" for them after defining the reference population demographically. Careful determination and verification or validation of RI by the laboratory are essential to ensure proper utility.
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 June 2018 to October 2019 after approval from Aga Khan University Hospital's ethical review committee.
Inclusion criteria included children less than six years of age, not suffering from any illness during the last two weeks and no hospitalization since the last four weeks. Children on vitamins or history of kidney stones or family history of kidney stones were excluded.
A standardized questionnaire was used, and recommended target sample size was calculated using CLSI Guidelines C28-A3. Non-probability (consecutive sampling) was done. Parents or guardians of each reference individual were invited to participate in the study. An explanation of the study, consent form (written in the local language, in accordance with the guidelines of the local ethics committee), and the procedure for participation were explained to the parents by the primary investigator. Those who consented were provided with a container for urine collection, and the procedure for the collection was explained. A 5ml random morning urine sample was collected and stored at -30 ºC until analysis after adding 6M hydrochloric acid.
Urinary Oxalate was measured on Micro lab 300 using a kit based on the oxalate oxidase principle by Trinity Biotech Plc, Wicklow, Ireland while creatinine was measured by kinetic Jaffe reaction ADVIA 1800 by Siemens Diagnostic, USA. Samples were analyzed in batches with quality control specimen for validating the results. Oxalate to creatinine ratio (Ox: Cr) was calculated. College of American Pathologist, USA accredits clinical Laboratory of Aga Khan University Hospital.
Data were analyzed by EP evaluator and SPSS 23. Subjects were categorized based on ages into five groups. Group I (0-6 months), Group II (6 months-1 years), Group III (1-2 years), Group IV (2-4 years), and Group V (4-6 years). Descriptive data were analyzed for frequencies and median with IQR. P-value <0.05 was taken as statistically significant.
- Conditions
- Hyperoxaluria
- Keywords
- Spot oxalate to creatinine ratio, Reference intervals
- Medical subject headings
- Hyperoxaluria
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of Reference Interval of Spot Urinary Oxalate to Creatinine Ratio in Children of Pakistani Origin Under Six Years of Age
To determine the spot urine oxalate to creatinine reference interval in children under six years of age for our population.
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 posted16 Feb 2021
- Study start1 Jun 2018
- Primary completion30 Oct 2019
- Study completion30 Oct 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 HyperoxaluriaStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (actual)
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, MBBS, Principal investigator, AKUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04756024
- Sponsor's protocol ID
- 2018-0232-345
- Status last verified
- Feb 2021
- First submitted
- 15 Feb 2021
- Last updated
- 16 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cochat P, Rumsby G. Primary hyperoxaluria. N Engl J Med. 2013 Aug 15;369(7):649-58. doi: 10.1056/NEJMra1301564. No abstract available.
PubMed 23944302Molla A, Khurshid M, Manser WT, Lalani R, Alam A, Mohammad Z. Suggested reference ranges in clinical chemistry for apparently healthy males and females of Pakistan. J Pak Med Assoc. 1993 Jun;43(6):113-5.
PubMed 8411612
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Reference Interval of Spot Urinary Oxalate to Creatinine Ratio in Children of Pakistani Origin Under Six Years of Age
- ClinicalTrials.gov ID
- NCT04756024
- Acronym / sponsor ID
- 2018-0232-345
- Conditions
- Hyperoxaluria
- Keywords
- Spot oxalate to creatinine ratio, Reference intervals
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 16 Feb 2021 (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.
Reference intervals (RI) of oxalate for the Pakistani population are not readily available. The values used by most labs are usually taken from the literature from studies mainly performed on Caucasian or from the manufacturer package insert of oxalate reagent kits [2]. RI of an analyte assist the clinician in differentiating between health and disease [3]. It is established by testing healthy populations and figuring out what appears to be "normal" for them after defining the reference population demographically. Careful determination and verification or validation of RI by the laboratory are essential to ensure proper utility.
Detailed description
A cross-sectional study was conducted at Section of Chemical Pathology, Department of Pathology and Laboratory Medicine, Aga Khan University, Karachi, from June 2018 to October 2019 after approval from Aga Khan University Hospital's ethical review committee.
Inclusion criteria included children less than six years of age, not suffering from any illness during the last two weeks and no hospitalization since the last four weeks. Children on vitamins or history of kidney stones or family history of kidney stones were excluded.
A standardized questionnaire was used, and recommended target sample size was calculated using CLSI Guidelines C28-A3. Non-probability (consecutive sampling) was done. Parents or guardians of each reference individual were invited to participate in the study. An explanation of the study, consent form (written in the local language, in accordance with the guidelines of the local ethics committee), and the procedure for participation were explained to the parents by the primary investigator. Those who consented were provided with a container for urine collection, and the procedure for the collection was explained. A 5ml random morning urine sample was collected and stored at -30 ºC until analysis after adding 6M hydrochloric acid.
Urinary Oxalate was measured on Micro lab 300 using a kit based on the oxalate oxidase principle by Trinity Biotech Plc, Wicklow, Ireland while creatinine was measured by kinetic Jaffe reaction ADVIA 1800 by Siemens Diagnostic, USA. Samples were analyzed in batches with quality control specimen for validating the results. Oxalate to creatinine ratio (Ox: Cr) was calculated. College of American Pathologist, USA accredits clinical Laboratory of Aga Khan University Hospital.
Data were analyzed by EP evaluator and SPSS 23. Subjects were categorized based on ages into five groups. Group I (0-6 months), Group II (6 months-1 years), Group III (1-2 years), Group IV (2-4 years), and Group V (4-6 years). Descriptive data were analyzed for frequencies and median with IQR. P-value <0.05 was taken as statistically significant.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 15 days to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Healthy children less than 6 years of age (both genders)
Key inclusion criteria (1 listed)
- Inclusion criteria included children less than six years of age, not suffering from any illness during the last two weeks and no hospitalization since the last four weeks.
Key exclusion criteria (1 listed)
- Children on vitamins or history of kidney stones or family history of kidney stones were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determination of Reference Interval of Spot Urinary Oxalate to Creatinine Ratio in Children of Pakistani Origin Under Six Years of Age
Time frame: 1 year
To determine the spot urine oxalate to creatinine reference interval in children under six years of age for our population.
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 16 Feb 2021.
- Results publication: PubMed 23944302Cochat P, Rumsby G. Primary hyperoxaluria. N Engl J Med. 2013 Aug 15;369(7):649-58. doi: 10.1056/NEJMra1301564. No abstract available.
- Results publication: PubMed 8411612Molla A, Khurshid M, Manser WT, Lalani R, Alam A, Mohammad Z. Suggested reference ranges in clinical chemistry for apparently healthy males and females of Pakistan. J Pak Med Assoc. 1993 Jun;43(6):113-5.
- 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, MBBS 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 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 1 inclusion and 1 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 16 Feb 2021. 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?
Determination of Reference Interval of Spot Urinary Oxalate to Creatinine Ratio in Children of Pakistani Origin Under Six Years of Age (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 NCT04756024, 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 16 Feb 2021; AzTrials last refreshed its copy on 7 Nov 2026.