Reference Interval of Spot Urinary Oxalate to Creatinine Ratio in Children

Status Completed

Clinical 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]. 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.

Clinical Trial 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

Related Conditions & MeSH terms

Hyperoxaluria

Clinical Trial Details

NCT number	NCT04756024
Study type	Observational
Source	Aga Khan University
Contact
Status	Completed
Phase
Start date	June 1, 2018
Completion date	October 30, 2019

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.