Effects of Vitamin D and Calcium Supplementation on Inflammatory Biomarkers and Adypocytokines in Diabetic Patients

Study Overview
=================
Brief Summary
-----------------
The epidemic of type 2 diabetes is an enormous public health problem in all parts of the world, with 366 million cases by 2030. Chronic inflammation has been postulated to play a role in the pathogenesis of type 2 diabetes. High levels of adiponectin and inflammatory biomarkers are known as a new risk factor for diabetes. There is accumulating evidence suggesting that altered vitamin D and calcium homeostasis affect the development of type 2 diabetes, but it is still unclear whether that effects are through reducing the level of adipocytokines and inflammatory biomarkers or not. This study has been designed to evaluate the effects of vitamin D and calcium supplementations alone and in combination on inflammatory biomarkers and adypocytokines in type 2 diabetic patients. This study is a single masked, controlled randomized trial with period of 8 weeks. 120 diabetic patients who met the inclusion criteria will enroll in this study. Subjects will randomly assign in to four groups. Randomization will be achieved by permuted blocks with stratification by age, sex, BMI, type of diabetes and dose of medication. Group1 will receive 50000 IU of vitamin D3 per week plus calcium placebo, group2 will received 1000 mg of calcium carbonate per day plus vitamin D placebo, group 3 will receive 50000 IU of vitamin D3 plus 100 of mg calcium carbonate per day and group four will receive calcium and vitamin D placebos. Total cholesterol, HDL, LDL, serum triglyceride, serum glucose, serum insulin, HbA1C, leptin, adiponectin and inflammatory biomarkers such as TNF-alpha, IL-6 and high sensitivity C reactive protein (hs-CRP) will be determine by taking blood samples at the baseline and at the end of intervention. Systolic and diastolic blood pressure and anthropometric measurements (height, weight, hip and waist circumferences) will be measured at the baseline and after 8 weeks of intervention. 3 dietary records and 3 physical activity records will be taken at 2,4 and 6 week of intervention to make sure that all subjects maintain their usual diet and physical activity during intervention.

Official Title
-----------------
Effects of Vitamin D and Calcium Supplementation on Inflammatory Biomarkers and Adypocytokines in Diabetic Patients

Conditions
-----------------
Nutritional and Metabolic Disease

Intervention / Treatment
-----------------
* Dietary Supplement: vitamin D3 supplement
* Dietary Supplement: calcium supplement
* Dietary Supplement: vitamin D3 and calcium supplement
* Dietary Supplement: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: more than 30 years old have no history of renal failure, cancer, liver diseases, thyroid diseases or any other inflammatory diseases have no allergy do not use any tobacco products not using corticosteroids not consuming any kinds of vitamin D or calcium supplement have not more than 4 kilograms weight change during last 3 months Exclusion Criteria: pregnancy insulin dependent diabetes

Ages Eligible for Study
-----------------
Minimum Age: 30 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: vitamin D3<br>vitamin D3 supplement 50000 IU vitamin D3 per week | Dietary Supplement: vitamin D3 supplement<br> <br> * Other names: cholecalciferol;|
| Experimental: calcium supplement<br>calcium supplement 1000 mg calcium carbonate daily | Dietary Supplement: calcium supplement<br> <br> * Other names: calcium carbonate;|
| Experimental: vitamin D and calcium supplement<br>vitamin D3 and calcium supplementation 50000 IU vitamin D3 per week and 1000 mg calcium carbonate daily | Dietary Supplement: vitamin D3 and calcium supplement<br> <br> * Other names: cholecalciferol and calcium carbonate;|
| Placebo Comparator: placebo<br>placebo | Dietary Supplement: placebo<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in inflammatory biomarkers from baseline at 8 weeks | including:IL-6, TNF-alpha, hs-CRP | 8 weeks | 
| change in adipocytokines from baseline at 8 weeks | including: adiponectin and leptin | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in weight (Kg) from baseline at 8 weeks |  | 8 weeks | 
| change in lipid profile from baseline at 8 weeks | including: LDL, HDL, total cholesterol, TG | 8 weeks | 
| change in serum Glucose from baseline at 8 weeks |  | 8 weeks | 
| change in height (Cms) from baseline at 8 weeks |  | 8 weeks | 
| change in hip circumference (Cms) from baseline at 8 weeks |  | 8 weeks | 
| change in waist circumference (Cms) from baseline at 8 weeks |  | 8 weeks | 
| change in serum Insulin from baseline at 8 weeks |  | 8 weeks | 
| change in HbA1C from baseline at 8 weeks |  | 8 weeks | 
| change in blood pressure from baseline at 8 weeks |  | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Calciol, Cholecalciferol, vitamin D3, Diabetes Mellitus, Diabetes Mellitus Type 2, glucose metabolism disorders, ergocalciferol, calcium, adipicytokines, inflammatory biomarkers