- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02906319
Vitamin D and HbA1c Levels in Diabetic Patients With CKD
Association Between Serum 25-hydroxyvitamin D Levels and Glycated Haemoglobin in Diabetic Patients With Chronic Kidney Disease
Study Overview
Status
Conditions
Detailed Description
This was a cross sectional study using consecutive sampling methodology for participant recruitment. It was carried out at the specialized diabetic, renal, and general outpatient clinics in the University of Malaya Medical Centre (UMMC), Kuala Lumpur, Malaysia.
Serum 25(OH)D levels were determined by using direct chemiluminesent immunoassay (ADVIA Centaur XP; Siemens Healthcare Diagnostics, Tarrytown, New York, USA). Serum HbA1c levels were determined using high-pressure liquid chromatography (Variant™ II Turbo; Bio-Rad, Hercules, California, USA).
Data collected will be analyzed using Statistical Package for Social Sciences SPSS version 23.0 for Windows, version 23.0 (IBM Corp., Armonk, New York, USA).
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- eGFR 15-59 ml/min/1.73m2
- age ≥ 18 years old
- able to provide informed consent
Exclusion Criteria:
- active infections
- autoimmune diseases
- malignancies
- on immunosuppressive therapy
- on vitamin D supplements
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
25-hydroxyvitamin D levels
Time Frame: Within 2 weeks from enrolment
|
The unit of measure was nmol/L.
The detection limit of the device was <10 nmol/L.
A mean value of 5 nmol/L were taken for results reported as <10nmol/L.
|
Within 2 weeks from enrolment
|
HbA1c levels
Time Frame: Within 2 weeks from enrolment
|
The unit of measure was percentage (using NGSP standarization).
|
Within 2 weeks from enrolment
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yong Muh Ng, MMed, University of Malaya
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201412-878
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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