Vitamin D and HbA1c Levels in Diabetic Patients With CKD

Completed

• Conditions: Vitamin D Deficiency; Diabetes Mellitus

• Registration Number: NCT02906319
• Lead Sponsor: Ng Yong Muh

Brief Summary

The purpose of this study is to determine the association between serum 25-hydroxyvitamin D and HbA1c levels in diabetic patients with chronic kidney disease. The investigators hypothesized that serum 25-hydroxyvitamin D levels were negatively correlated with HbA1c levels.

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 Timeline

• Study Start: 2015-09
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2016-09
• Study First Submitted: 2016-09-09
• Study First Submitted QC: 2016-09-14
• Last Update Submitted: 2016-09-14
• Study First Posted: 2016-09-20
• Last Update Posted: 2016-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HbA1c levels	Within 2 weeks from enrolment	The unit of measure was percentage (using NGSP standarization).
25-hydroxyvitamin D levels	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.