Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04756024
Status:
COMPLETED
Last Update Posted:
2021-02-16
First Post:
2021-02-15
Brief Title:
Reference Interval of Spot Urinary Oxalate to Creatinine Ratio in Children
Sponsor:
Aga Khan University
Organization:
Aga Khan University
Study Overview
Official Title:
Determination of Reference Interval of Spot Urinary Oxalate to Creatinine Ratio in Children of Pakistani Origin Under Six Years of Age
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 Hospitals 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 005 was taken as statistically significant
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 005 was taken as statistically significant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None