Effect of Vitamin D Supplementation on Inflammatory Markers

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Vitamin D Deficiency, Type2 Diabetes

Intervention / Treatment
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* Dietary Supplement: cholecalciferol (Euro-Pharm International, Canada)
* Dietary Supplement: Placebo tablet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 72 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: In this randomized, controlled, double blind study, participants were randomized (using the simple randomization method) to receive either a supplement of 10,000 IU of cholecalciferol (Euro-Pharm International, Canada) or a placebo tablet (containing microcrystalline cellulose: 66.3%, starch: 33.2%, magnesium stearate: 0.5%, per serving) to be taken 3 times a week for a period of six months
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment group<br>Group receiving a supplement of 10,000 IU of cholecalciferol (Euro-Pharm International, Canada) to be taken 3 times a week for a period of six months. | Dietary Supplement: cholecalciferol (Euro-Pharm International, Canada)<br>* 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<br>|
| Placebo Comparator: Placebo group<br>Group receiving a placebo tablet (containing microcrystalline cellulose: 66.3%, starch: 33.2%, magnesium stearate: 0.5%, per serving) to be taken 3 times a week for a period of six months | Dietary Supplement: Placebo tablet<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline fasting blood glucose (FBG) at 6 months | FASTING BLOOD GLUCOSE | baseline and after 6 months of intervention | 
| Change from Baseline Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) at 6 months | Homeostatic Model Assessment of Insulin Resistance | baseline and after 6 months of intervention | 
| Change from Baseline C-reactive protein (CRP) at 6 months | C-reactive protein | baseline and after 6 months of intervention | 
| Change from Baseline Interleukin-6 (IL-6) at 6 months | Interleukin-6 | baseline and after 6 months of intervention | 
| Change from Baseline TNF-alpha at 6 months | TNF-alpha | baseline and after 6 months of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline weight at 6 months | weight change | baseline and after 6 months of intervention | 
| Change from Baseline Body Mass Index (BMI) at 6 months | Body mass index | baseline and after 6 months of intervention | 
| Change from Baseline waist circumference at 6 months | Waist circumference change | baseline and after 6 months of intervention | 
| Change from Baseline Percentage of fat at 6 months | Percentage of fat | baseline and after 6 months of intervention | 
| Change from Baseline Parathyroid hormone (PTH) at 6 months | Parathyroid hormone | baseline and after 6 months of intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vitamin D, type 2 diabetes, inflammation