Effects of Vitamin D and Calcium Supplementation on Inflammatory Biomarkers and Adypocytokines in Diabetic Patients
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 29, 2012
CompletedFirst Posted
Study publicly available on registry
August 10, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedAugust 13, 2012
August 1, 2012
1 year
July 29, 2012
August 10, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
change in inflammatory biomarkers from baseline at 8 weeks
including:IL-6, TNF-alpha, hs-CRP
8 weeks
change in adipocytokines from baseline at 8 weeks
including: adiponectin and leptin
8 weeks
Secondary Outcomes (9)
change in weight (Kg) from baseline at 8 weeks
8 weeks
change in lipid profile from baseline at 8 weeks
8 weeks
change in serum Glucose from baseline at 8 weeks
8 weeks
change in height (Cms) from baseline at 8 weeks
8 weeks
change in hip circumference (Cms) from baseline at 8 weeks
8 weeks
- +4 more secondary outcomes
Study Arms (4)
vitamin D3
EXPERIMENTALvitamin D3 supplement 50000 IU vitamin D3 per week
calcium supplement
EXPERIMENTALcalcium supplement 1000 mg calcium carbonate daily
vitamin D and calcium supplement
EXPERIMENTALvitamin D3 and calcium supplementation 50000 IU vitamin D3 per week and 1000 mg calcium carbonate daily
placebo
PLACEBO COMPARATORplacebo
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- pregnancy
- insulin dependent diabetes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical School of Isfahan
Isfahan, Isfahan, Iran
Related Publications (3)
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.
PMID: 25738212DERIVEDTabesh 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.
PMID: 25215557DERIVEDTabesh 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.
PMID: 25005333DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
July 29, 2012
First Posted
August 10, 2012
Study Start
February 1, 2012
Primary Completion
February 1, 2013
Last Updated
August 13, 2012
Record last verified: 2012-08