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

Isfahan University of Medical Sciences

Status: Unknown

Conditions: Nutritional and Metabolic Disease

Treatments: Dietary Supplement: vitamin D3 supplement; Dietary Supplement: placebo; Dietary Supplement: calcium supplement; Dietary Supplement: vitamin D3 and calcium supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT01662193

190136

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 4 patient groups, including a placebo group

vitamin D3

Experimental group

Description:

vitamin D3 supplement 50000 IU vitamin D3 per week

Treatment:

Dietary Supplement: vitamin D3 supplement

calcium supplement

Experimental group

Description:

calcium supplement 1000 mg calcium carbonate daily

Treatment:

Dietary Supplement: calcium supplement

vitamin D and calcium supplement

Experimental group

Description:

vitamin D3 and calcium supplementation 50000 IU vitamin D3 per week and 1000 mg calcium carbonate daily

Treatment:

Dietary Supplement: vitamin D3 and calcium supplement

placebo

Placebo Comparator group

Description:

placebo

Treatment:

Dietary Supplement: placebo