Vitamin D and HbA1c Levels in Diabetic Patients With CKD

Diabetes Mellitus Clinical Trial

Official title:

Association Between Serum 25-hydroxyvitamin D Levels and Glycated Haemoglobin in Diabetic Patients With Chronic Kidney Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02906319
• Other study ID #: 201412-878
• Status: Completed
• Phase: N/A
• First received: September 9, 2016
• Last updated: September 14, 2016
• Start date: September 2015
• Est. completion date: July 2016

Study information

• Verified date: September 2016
• Source: University of Malaya
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malaysia: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Diabetes Mellitus
• Vitamin D Deficiency

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Ng Yong Muh	Malaysian Society of Nephrology, University of Malaya

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	25-hydroxyvitamin D levels	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	No
Primary	HbA1c levels	The unit of measure was percentage (using NGSP standarization).	Within 2 weeks from enrolment	No