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Completed

NCT Number: NCT03782805

Effect of Vitamin D Supplementation on Inflammatory Markers

Previous studies have shown that improving vitamin D status among the elderly may lead to an improvement in some inflammatory markers, especially with patients with type 2 diabetes. The aim of our trial is study the effect of vitamin D supplementation on inflammatory markers in patients having type 2 diabetes.

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Key information

Conditions

Vitamin D Deficiency Avitaminosis Deficiency Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Inflammation Malnutrition Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Type2 Diabetes

Age range

60 year–72 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Saint Charles Hospital

Beirut, 64, Lebanon

About this study

Vitamin D was shown crucial for insulin secretion and glucose homeostasis. Furthermore, one of the markers of type 2 diabetes is low-grade inflammation, which can be the result of an elevated circulation of cytokines. High amounts of circulating inflammatory cytokines such as tumor necrosis factor-alpha (TNF-α) and interleukin-6 (IL-6) contribute significantly to insulin resistance in muscle and adipose tissues. The aim of this randomized, controlled, double blind study is to examine the effect of vitamin D supplementation on some inflammatory markers in older Lebanese patients having type 2 diabetes.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects deficient in vitamin D
  • Subjects having type 2 diabetes
  • Non-obese subjects

Exclusion criteria

  • Subjects having hyperparathyroidism
  • Subjects suffering from hepatic disease / kidney disease

Treatment and study plan

cholecalciferol (Euro-Pharm International, Canada)

Dietary Supplement

The participants are randomly asked to take either a pill containing either a supplement of cholecalciferol or placebo for 3 times a week, within a period of 6 months

Placebo Tablet

Dietary Supplement

The participants are randomly asked to take either a pill containing either a supplement of cholecalciferol or placebo for 3 times a week, within a period of 6 months

Primary outcomes

  1. Change from Baseline fasting blood glucose (FBG) at 6 months

    Time frame: baseline and after 6 months of intervention

    FASTING BLOOD GLUCOSE

  2. Change from Baseline Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) at 6 months

    Time frame: baseline and after 6 months of intervention

    Homeostatic Model Assessment of Insulin Resistance

  3. Change from Baseline C-reactive protein (CRP) at 6 months

    Time frame: baseline and after 6 months of intervention

    C-reactive protein

  4. Change from Baseline Interleukin-6 (IL-6) at 6 months

    Time frame: baseline and after 6 months of intervention

    Interleukin-6

  5. Change from Baseline TNF-alpha at 6 months

    Time frame: baseline and after 6 months of intervention

    TNF-alpha

Secondary outcomes

  1. Change from Baseline weight at 6 months

    Time frame: baseline and after 6 months of intervention

    weight change

  2. Change from Baseline Body Mass Index (BMI) at 6 months

    Time frame: baseline and after 6 months of intervention

    Body mass index

  3. Change from Baseline waist circumference at 6 months

    Time frame: baseline and after 6 months of intervention

    Waist circumference change

  4. Change from Baseline Percentage of fat at 6 months

    Time frame: baseline and after 6 months of intervention

    Percentage of fat

  5. Change from Baseline Parathyroid hormone (PTH) at 6 months

    Time frame: baseline and after 6 months of intervention

    Parathyroid hormone

Sponsors and collaborators

Lead sponsor

Université d'Auvergne

Other

Registry information

Official study title

Effect of Vitamin D Treatment on Some Inflammatory Markers in Non-obese Lebanese Patients With Type 2 Diabetes

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Dec 20, 2018
Registry last updated
Dec 21, 2018

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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