NCT04571359

Brief 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. 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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2019

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 1, 2020

Completed
Last Updated

October 1, 2020

Status Verified

September 1, 2020

Enrollment Period

11 months

First QC Date

September 27, 2020

Last Update Submit

September 30, 2020

Conditions

Keywords

24-hour urinary oxalateSpot oxalate to creatinine ratio

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 year

Interventions

Comparsion between 24 hours urine oxalate and spot urine oxalate to creatinine ratio

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with history of kidney stones presenting at the Clinical Laboratory for 24 hours urine oxalate estimation.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Syed bilal hashmi

Karachi, Pakistan, Sindh, 75800, Pakistan

Location

Related Publications (2)

  • 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.

    PMID: 4576881BACKGROUND
  • Hoppe B. An update on primary hyperoxaluria. Nat Rev Nephrol. 2012 Jun 12;8(8):467-75. doi: 10.1038/nrneph.2012.113.

    PMID: 22688746BACKGROUND

MeSH Terms

Conditions

UrolithiasisHyperoxaluria

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesKidney Diseases

Study Officials

  • Syed bilal hashmi

    AKUH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

September 27, 2020

First Posted

October 1, 2020

Study Start

February 1, 2019

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

October 1, 2020

Record last verified: 2020-09

Locations