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Vitamin D and HbA1c Levels in Diabetic Patients With CKD

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ClinicalTrials.gov Identifier: NCT02906319
Recruitment Status : Completed
First Posted : September 20, 2016
Last Update Posted : September 20, 2016
Sponsor:
Collaborators:
University of Malaya
Malaysian Society of Nephrology
Information provided by (Responsible Party):
Ng Yong Muh, University of Malaya

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.

Condition or disease
Vitamin D Deficiency Diabetes Mellitus

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 : Observational
Actual Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Association Between Serum 25-hydroxyvitamin D Levels and Glycated Haemoglobin in Diabetic Patients With Chronic Kidney Disease
Study Start Date : September 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D




Primary Outcome Measures :
  1. 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.

  2. HbA1c levels [ Time Frame: Within 2 weeks from enrolment ]
    The unit of measure was percentage (using NGSP standarization).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who attended specialized diabetic, renal, and general outpatient clinics in the University of Malaya Medical Centre (UMMC), Kuala Lumpur, Malaysia.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02906319


Sponsors and Collaborators
Ng Yong Muh
University of Malaya
Malaysian Society of Nephrology
Investigators
Principal Investigator: Yong Muh Ng, MMed University of Malaya

Responsible Party: Ng Yong Muh, Dr, University of Malaya
ClinicalTrials.gov Identifier: NCT02906319     History of Changes
Other Study ID Numbers: 201412-878
First Posted: September 20, 2016    Key Record Dates
Last Update Posted: September 20, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: A dataset of participants' clinical characteristics and biochemical tests result. The data was obtained directly from the participants and via Laboratory Information System. It is ready for submission.

Additional relevant MeSH terms:
Diabetes Mellitus
Vitamin D Deficiency
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders