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

August 10, 2012 updated by: Marjan Tabesh, Isfahan University of Medical Sciences

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Dietary supplement: placebo
Experimental: vitamin D3
vitamin D3 supplement 50000 IU vitamin D3 per week
Dietary supplement: vitamin D3 supplement
Other Names:
  • cholecalciferol
Experimental: calcium supplement
calcium supplement 1000 mg calcium carbonate daily
Dietary supplement: calcium supplement
Other Names:
  • calcium carbonate
Experimental: vitamin D and calcium supplement
vitamin D3 and calcium supplementation 50000 IU vitamin D3 per week and 1000 mg calcium carbonate daily
Dietary supplement: vitamin D3 and calcium supplement
Other Names:
  • cholecalciferol and calcium carbonate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in inflammatory biomarkers from baseline at 8 weeks
Time Frame: 8 weeks
including:IL-6, TNF-alpha, hs-CRP
8 weeks
change in adipocytokines from baseline at 8 weeks
Time Frame: 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
Time Frame: 8 weeks
8 weeks
change in lipid profile from baseline at 8 weeks
Time Frame: 8 weeks
including: LDL, HDL, total cholesterol, TG
8 weeks
change in serum Glucose from baseline at 8 weeks
Time Frame: 8 weeks
8 weeks
change in height (Cms) from baseline at 8 weeks
Time Frame: 8 weeks
8 weeks
change in hip circumference (Cms) from baseline at 8 weeks
Time Frame: 8 weeks
8 weeks
change in waist circumference (Cms) from baseline at 8 weeks
Time Frame: 8 weeks
8 weeks
change in serum Insulin from baseline at 8 weeks
Time Frame: 8 weeks
8 weeks
change in HbA1C from baseline at 8 weeks
Time Frame: 8 weeks
8 weeks
change in blood pressure from baseline at 8 weeks
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Isfahan University of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Anticipated)

February 1, 2013

Study Registration Dates

First Submitted

July 29, 2012

First Submitted That Met QC Criteria

August 7, 2012

First Posted (Estimate)

August 10, 2012

Study Record Updates

Last Update Posted (Estimate)

August 13, 2012

Last Update Submitted That Met QC Criteria

August 10, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 190136

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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