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Completed

NCT Number: NCT02906319

Vitamin D and HbA1c Levels in Diabetic Patients With CKD

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.

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Key information

Conditions

Vitamin D Deficiency Avitaminosis Deficiency Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Malnutrition Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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).

Sponsors and collaborators

Lead sponsor

Ng Yong Muh

Other

Collaborators

  • Malaysian Society of Nephrology
  • University of Malaya

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 20, 2016
Registry last updated
Sep 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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