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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Isfahan University of Medical Sciences.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Marjan Tabesh, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01662193
First received: July 29, 2012
Last updated: August 10, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention
Nutritional and Metabolic Disease
Dietary Supplement: vitamin D3 supplement
Dietary Supplement: calcium supplement
Dietary Supplement: vitamin D3 and calcium supplement
Dietary Supplement: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Effects of Vitamin D and Calcium Supplementation on Inflammatory Biomarkers and Adypocytokines in Diabetic Patients

Resource links provided by NLM:


Further study details as provided by Isfahan University of Medical Sciences:

Primary Outcome Measures:
  • change in inflammatory biomarkers from baseline at 8 weeks [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    including:IL-6, TNF-alpha, hs-CRP

  • change in adipocytokines from baseline at 8 weeks [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    including: adiponectin and leptin


Secondary Outcome Measures:
  • change in weight (Kg) from baseline at 8 weeks [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • change in lipid profile from baseline at 8 weeks [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    including: LDL, HDL, total cholesterol, TG

  • change in serum Glucose from baseline at 8 weeks [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • change in height (Cms) from baseline at 8 weeks [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • change in hip circumference (Cms) from baseline at 8 weeks [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • change in waist circumference (Cms) from baseline at 8 weeks [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • change in serum Insulin from baseline at 8 weeks [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • change in HbA1C from baseline at 8 weeks [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • change in blood pressure from baseline at 8 weeks [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: February 2012
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: vitamin D3
vitamin D3 supplement 50000 IU vitamin D3 per week
Dietary Supplement: vitamin D3 supplement
Other Name: cholecalciferol
Experimental: calcium supplement
calcium supplement 1000 mg calcium carbonate daily
Dietary Supplement: calcium supplement
Other Name: 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 Name: cholecalciferol and calcium carbonate
Placebo Comparator: placebo
placebo
Dietary Supplement: placebo

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01662193

Contacts
Contact: marjan tabesh, MS 00989131664159 tabesh@hlth.mui.ac.ir

Locations
Iran, Islamic Republic of
Medical School of Isfahan Recruiting
Isfahan, Iran, Islamic Republic of
Contact: esmaillzadeh, PhD       esmaillzadeh@hlth.mui.ac.ir   
Principal Investigator: marjan tabesh, MS         
Sponsors and Collaborators
Isfahan University of Medical Sciences
  More Information

No publications provided

Responsible Party: Marjan Tabesh, Director, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01662193     History of Changes
Other Study ID Numbers: 190136
Study First Received: July 29, 2012
Last Updated: August 10, 2012
Health Authority: Iran:medical school of isfahan

Keywords provided by Isfahan University of Medical Sciences:
Cholecalciferol
Calciol
vitamin D3
Diabetes Mellitus
Diabetes Mellitus Type 2
glucose metabolism disorders
ergocalciferol
calcium
adipicytokines
inflammatory biomarkers

Additional relevant MeSH terms:
Calcium, Dietary
Metabolic Diseases
Cholecalciferol
Vitamin D
Ergocalciferols
Calcium Carbonate
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Antacids
Molecular Mechanisms of Pharmacological Action
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on August 28, 2014