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

Not Applicable

• Conditions: Nutritional and Metabolic Disease
• Interventions: Dietary Supplement: vitamin D3 supplement; Dietary Supplement: calcium supplement; Dietary Supplement: vitamin D3 and calcium supplement; Dietary Supplement: placebo

• Registration Number: NCT01662193
• Lead Sponsor: Isfahan University of Medical Sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-07-29
• Status Verified: 2012-08
• Study First Submitted QC: 2012-08-07
• Study First Posted: 2012-08-10
• Last Update Submitted: 2012-08-10
• Last Update Posted: 2012-08-13
• Primary Completion: 2013-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
vitamin D3	vitamin D3 supplement	vitamin D3 supplement 50000 IU vitamin D3 per week
calcium supplement	calcium supplement	calcium supplement 1000 mg calcium carbonate daily
vitamin D and calcium supplement	vitamin D3 and calcium supplement	vitamin D3 and calcium supplementation 50000 IU vitamin D3 per week and 1000 mg calcium carbonate daily
placebo	placebo	placebo

Primary Outcome Measures

Name	Time	Method
change in inflammatory biomarkers from baseline at 8 weeks	8 weeks	including:IL-6, TNF-alpha, hs-CRP
change in adipocytokines from baseline at 8 weeks	8 weeks	including: adiponectin and leptin

Secondary Outcome Measures

Name	Time	Method
change in weight (Kg) from baseline at 8 weeks	8 weeks
change in lipid profile from baseline at 8 weeks	8 weeks	including: LDL, HDL, total cholesterol, TG
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

Trial Locations

Locations (1)

Medical School of Isfahan; 🇮🇷 Isfahan, Iran, Islamic Republic of