Establishment of Aldosterone and Renin Reference Range
ARR
Establishment of Reference Ranges for Aldosterone and Renin in a Multi-racial Community Using the Chemiluminescent Immunoassay (CLIA)
1 other identifier
observational
300
1 country
1
Brief Summary
Elevated aldosterone levels were also shown to contribute to the excess morbidity and mortality. Literature shows aldosterone and renin levels differ between ethnicity and gender. There is no established reference intervals for these two hormone levels in Asian community. We aim to establish reference intervals for plasma aldosterone and direct renin concentrations among Malaysians residing in Sarawak using the chemiluminescent immunoassay (CLIA). This is a cross-sectional study which will be conducted among ambulatory patients, healthy blood donors and healthy volunteers. 300 participants who fulfil study criteria will be recruited after informed consent. Socio-demographic data and anthropometric measurements will be recorded. Blood will be taken for plasma aldosterone, renin, serum potassium and creatinine. Urine will be collected for estimation of 24-hour sodium excretion. Aldosterone and renin reference intervals will be established partitioned for gender.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2021
1 active site
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
December 15, 2021
CompletedFirst Submitted
Initial submission to the registry
January 30, 2022
CompletedFirst Posted
Study publicly available on registry
February 9, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedFebruary 9, 2022
January 1, 2022
2 years
January 30, 2022
January 30, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Aldosterone and renin reference intervals
24 months
Secondary Outcomes (1)
Aldosterone and renin reference intervals partitioned for gender
24 months
Eligibility Criteria
Ambulatory healthy volunteers
You may qualify if:
- aged 18 years old and above
- agreeable to participate in this study
- normal kidney function (eGFR\>60ml/min/1.73m2)
- Malaysian
- BMI\<27.5kg/m2
You may not qualify if:
- taking prescribed/OTC medications within 3 months of study
- taking estrogen, either in oral contraceptive pills or hormone replacement therapy
- having hypertension defined as blood pressure\>140/90mmHg or on anti-hypertensive
- having hypokalemia (serum potassium \<3.5mmol/L)
- pregnant
- smoker
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universiti Malaysia Sarawak
Kuching, Sarawak, 93350, Malaysia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 30, 2022
First Posted
February 9, 2022
Study Start
December 15, 2021
Primary Completion
December 1, 2023
Study Completion
December 1, 2023
Last Updated
February 9, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will not share