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

Nutritional and Metabolic Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01662193
• Other study ID #: 190136
• Status: Recruiting
• Phase: N/A
• First received: July 29, 2012
• Last updated: August 10, 2012
• Start date: February 2012

Study information

• Verified date: August 2012
• Source: Isfahan University of Medical Sciences
• Contact: marjan tabesh, MS
• Phone: 00989131664159
• Email: tabesh[@]hlth.mui.ac.ir
• Is FDA regulated: No
• Health authority: Iran:medical school of isfahan
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metabolic Diseases
• Nutritional and Metabolic Disease

Intervention

Dietary Supplement:
• vitamin D3 supplement

• calcium supplement

• vitamin D3 and calcium supplement

• placebo

Locations

Country	Name	City	State
Iran, Islamic Republic of	Medical School of Isfahan	Isfahan

Sponsors (1)

Lead Sponsor	Collaborator
Isfahan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in inflammatory biomarkers from baseline at 8 weeks	including:IL-6, TNF-alpha, hs-CRP	8 weeks	No
Primary	change in adipocytokines from baseline at 8 weeks	including: adiponectin and leptin	8 weeks	No
Secondary	change in weight (Kg) from baseline at 8 weeks		8 weeks	No
Secondary	change in lipid profile from baseline at 8 weeks	including: LDL, HDL, total cholesterol, TG	8 weeks	No
Secondary	change in serum Glucose from baseline at 8 weeks		8 weeks	No
Secondary	change in height (Cms) from baseline at 8 weeks		8 weeks	No
Secondary	change in hip circumference (Cms) from baseline at 8 weeks		8 weeks	No
Secondary	change in waist circumference (Cms) from baseline at 8 weeks		8 weeks	No
Secondary	change in serum Insulin from baseline at 8 weeks		8 weeks	No
Secondary	change in HbA1C from baseline at 8 weeks		8 weeks	No
Secondary	change in blood pressure from baseline at 8 weeks		8 weeks	No