Effects of Vitamin D and Calcium Supplementation on Inflammatory Biomarkers and Adypocytokines in Diabetic Patients
Primary Purpose
Nutritional and Metabolic Disease
Status
Unknown status
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
vitamin D3 supplement
calcium supplement
vitamin D3 and calcium supplement
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Nutritional and Metabolic Disease focused on measuring Cholecalciferol, Calciol, vitamin D3, Diabetes Mellitus, Diabetes Mellitus Type 2, glucose metabolism disorders, ergocalciferol, calcium, adipicytokines, inflammatory biomarkers
Eligibility 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
Sites / Locations
- Medical School of IsfahanRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
vitamin D3
calcium supplement
vitamin D and calcium supplement
placebo
Arm Description
vitamin D3 supplement 50000 IU vitamin D3 per week
calcium supplement 1000 mg calcium carbonate daily
vitamin D3 and calcium supplementation 50000 IU vitamin D3 per week and 1000 mg calcium carbonate daily
placebo
Outcomes
Primary Outcome Measures
change in inflammatory biomarkers from baseline at 8 weeks
including:IL-6, TNF-alpha, hs-CRP
change in adipocytokines from baseline at 8 weeks
including: adiponectin and leptin
Secondary Outcome Measures
change in weight (Kg) from baseline at 8 weeks
change in lipid profile from baseline at 8 weeks
including: LDL, HDL, total cholesterol, TG
change in serum Glucose from baseline at 8 weeks
change in height (Cms) from baseline at 8 weeks
change in hip circumference (Cms) from baseline at 8 weeks
change in waist circumference (Cms) from baseline at 8 weeks
change in serum Insulin from baseline at 8 weeks
change in HbA1C from baseline at 8 weeks
change in blood pressure from baseline at 8 weeks
Full Information
NCT ID
NCT01662193
First Posted
July 29, 2012
Last Updated
August 10, 2012
Sponsor
Isfahan University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01662193
Brief Title
Effects of Vitamin D and Calcium Supplementation on Inflammatory Biomarkers and Adypocytokines in Diabetic Patients
Official Title
Effects of Vitamin D and Calcium Supplementation on Inflammatory Biomarkers and Adypocytokines in Diabetic Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Unknown status
Study Start Date
February 2012 (undefined)
Primary Completion Date
February 2013 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Isfahan University of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nutritional and Metabolic Disease
Keywords
Cholecalciferol, Calciol, vitamin D3, Diabetes Mellitus, Diabetes Mellitus Type 2, glucose metabolism disorders, ergocalciferol, calcium, adipicytokines, inflammatory biomarkers
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
vitamin D3
Arm Type
Experimental
Arm Description
vitamin D3 supplement 50000 IU vitamin D3 per week
Arm Title
calcium supplement
Arm Type
Experimental
Arm Description
calcium supplement 1000 mg calcium carbonate daily
Arm Title
vitamin D and calcium supplement
Arm Type
Experimental
Arm Description
vitamin D3 and calcium supplementation 50000 IU vitamin D3 per week and 1000 mg calcium carbonate daily
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
vitamin D3 supplement
Other Intervention Name(s)
cholecalciferol
Intervention Type
Dietary Supplement
Intervention Name(s)
calcium supplement
Other Intervention Name(s)
calcium carbonate
Intervention Type
Dietary Supplement
Intervention Name(s)
vitamin D3 and calcium supplement
Other Intervention Name(s)
cholecalciferol and calcium carbonate
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
change in inflammatory biomarkers from baseline at 8 weeks
Description
including:IL-6, TNF-alpha, hs-CRP
Time Frame
8 weeks
Title
change in adipocytokines from baseline at 8 weeks
Description
including: adiponectin and leptin
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
change in weight (Kg) from baseline at 8 weeks
Time Frame
8 weeks
Title
change in lipid profile from baseline at 8 weeks
Description
including: LDL, HDL, total cholesterol, TG
Time Frame
8 weeks
Title
change in serum Glucose from baseline at 8 weeks
Time Frame
8 weeks
Title
change in height (Cms) from baseline at 8 weeks
Time Frame
8 weeks
Title
change in hip circumference (Cms) from baseline at 8 weeks
Time Frame
8 weeks
Title
change in waist circumference (Cms) from baseline at 8 weeks
Time Frame
8 weeks
Title
change in serum Insulin from baseline at 8 weeks
Time Frame
8 weeks
Title
change in HbA1C from baseline at 8 weeks
Time Frame
8 weeks
Title
change in blood pressure from baseline at 8 weeks
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
marjan tabesh, MS
Phone
00989131664159
Email
tabesh@hlth.mui.ac.ir
Facility Information:
Facility Name
Medical School of Isfahan
City
Isfahan
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
esmaillzadeh, PhD
Email
esmaillzadeh@hlth.mui.ac.ir
First Name & Middle Initial & Last Name & Degree
marjan tabesh, MS
12. IPD Sharing Statement
Citations:
PubMed Identifier
25738212
Citation
Tabesh M, Azadbakht L, Faghihimani E, Tabesh M, Esmaillzadeh A. Effects of Calcium Plus Vitamin D Supplementation on Anthropometric Measurements and Blood Pressure in Vitamin D Insufficient People with Type 2 Diabetes: A Randomized Controlled Clinical Trial. J Am Coll Nutr. 2015;34(4):281-9. doi: 10.1080/07315724.2014.905761. Epub 2015 Mar 4.
Results Reference
derived
PubMed Identifier
25215557
Citation
Tabesh M, Azadbakht L, Faghihimani E, Tabesh M, Esmaillzadeh A. Calcium-vitamin D cosupplementation influences circulating inflammatory biomarkers and adipocytokines in vitamin D-insufficient diabetics: a randomized controlled clinical trial. J Clin Endocrinol Metab. 2014 Dec;99(12):E2485-93. doi: 10.1210/jc.2014-1977.
Results Reference
derived
PubMed Identifier
25005333
Citation
Tabesh M, Azadbakht L, Faghihimani E, Tabesh M, Esmaillzadeh A. Effects of calcium-vitamin D co-supplementation on metabolic profiles in vitamin D insufficient people with type 2 diabetes: a randomised controlled clinical trial. Diabetologia. 2014 Oct;57(10):2038-47. doi: 10.1007/s00125-014-3313-x. Epub 2014 Jul 10.
Results Reference
derived
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Effects of Vitamin D and Calcium Supplementation on Inflammatory Biomarkers and Adypocytokines in Diabetic Patients
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