NCT04756024

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2019

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

February 15, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 16, 2021

Completed
Last Updated

February 16, 2021

Status Verified

February 1, 2021

Enrollment Period

1.4 years

First QC Date

February 15, 2021

Last Update Submit

February 15, 2021

Conditions

Hyperoxaluria

Keywords

Spot oxalate to creatinine ratioReference intervals

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 year

Eligibility Criteria

Age15 Days - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Healthy children less than 6 years of age (both genders)

You may not qualify if:

  • Children on vitamins or history of kidney stones or family history of kidney stones were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Syed bilal hashmi

Karachi, Sindh, 75800, Pakistan

Location

Related Publications (2)

  • Cochat P, Rumsby G. Primary hyperoxaluria. N Engl J Med. 2013 Aug 15;369(7):649-58. doi: 10.1056/NEJMra1301564. No abstract available.

    PMID: 23944302RESULT

  • Molla 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.

    PMID: 8411612RESULT

MeSH Terms

Conditions

Hyperoxaluria

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Syed bilal hashmi, MBBS

    AKUH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

February 15, 2021

First Posted

February 16, 2021

Study Start

June 1, 2018

Primary Completion

October 30, 2019

Study Completion

October 30, 2019

Last Updated

February 16, 2021

Record last verified: 2021-02

Locations

PA(1)