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Vitamin D and HbA1c Levels in Diabetic Patients With CKD

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02906319
First Posted: September 20, 2016
Last Update Posted: September 20, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
University of Malaya
Malaysian Society of Nephrology
Information provided by (Responsible Party):
Ng Yong Muh, University of Malaya
  Purpose
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
Vitamin D Deficiency Diabetes Mellitus

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Ng Yong Muh, University of Malaya:

Primary Outcome Measures:
  • 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.

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


Enrollment: 100
Study Start Date: September 2015
Study Completion Date: July 2016
Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
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).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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
  More Information

Responsible Party: Ng Yong Muh, Dr, University of Malaya
ClinicalTrials.gov Identifier: NCT02906319     History of Changes
Other Study ID Numbers: 201412-878
First Submitted: September 9, 2016
First Posted: September 20, 2016
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