Protocol summary

Summary
This study has been designed to evaluate the effects of vitamin D and calcium supplementations alone and in combination on inflammatory biomarkers and adypocytocins in type 2 diabetic patients. This study is a controlled randomized trial with period of 8 weeks. 120 subjects will select from Isfahan Endocrine and Metabolism Research Center. Inclusion Criteria included more than 30 years old; not pregnant; do not use any tobacco products; do not inject insulin; not consuming any kinds of vitamin D or calcium supplement during last 8 weeks. Exclusion criteria included become pregnant and incidence of allergies. 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.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012072910433N1
Registration date: 2012-08-19, 1391/05/29
Registration timing: prospective

Last update:
Update count: 0
Registration date
2012-08-19, 1391/05/29
Registrant information
Name
Marjan Tabesh
Name of organization / entity
Medical school of Isfahan
Country
Iran (Islamic Republic of)
Phone
+98 31 1650 1828
Email address
tabesh@hlth.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Medical School of Isfahan and Food security research center
Expected recruitment start date
2012-08-22, 1391/06/01
Expected recruitment end date
2013-01-20, 1391/11/01
Actual recruitment start date
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Actual recruitment end date
empty
Trial completion date
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Scientific title
Effects of vitamin D and calcium supplementation on inflammatory biomarkers and adipocytokins in patients with type 2 diabetes
Public title
Effects of vitamin D and calcium supplementation in type 2 diabetic patient
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: more than 30 years old; not pregnant; do not use any tobacco products; do not inject insulin; have no history of renal failure, cancer, liver diseases, thyroid diseases or any other inflammatory diseases; not using corticosteroids; have not more than 4 kilograms weight change during last 3 months; not consuming any kinds of vitamin D or calcium supplement during last 8 weeks. Exclusion Criteria: Pregnancy; Allergy, trauma or surgery.
Age
From 30 years old to 149 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Isfahan University of Medical Science
Street address
Hezarjerib st. Medical School of Isfahan,Iran
City
Isfahan
Postal code
Approval date
2012-02-20, 1390/12/01
Ethics committee reference number
190136

Health conditions studied

1

Description of health condition studied
Type 2 diabetes
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus

Primary outcomes

1

Description
Inflammatory Biomarkers
Timepoint
at baseline and after 8 weeks of intervention
Method of measurement
Blood sample and standard methods

2

Description
Adipocytokins including Adiponectin and Leptin
Timepoint
at baseline and after 8 weeks of intervention
Method of measurement
Blood sample and standard methods

Secondary outcomes

1

Description
Antropometric Measurments( height, weight,hip and waist circumferences)
Timepoint
at the baseline and after 8 weeks of intervention
Method of measurement
height, hip and waist circumferences in cm and weight in kg by standard methods

2

Description
Blood pressure
Timepoint
at the baseline and after 8 weeks of intervention
Method of measurement
mmHg

Intervention groups

1

Description
50000 IUvitamin D3 per week plus calcium placebo for 8 weeks
Category
Other

2

Description
1000 mg calcium carbonate per day plus vitamin D3 placebo for 8 weeks
Category
Other

3

Description
50000 IU vitamin D3 per week plus 1000 mg calcium carbonate per day for 8 weeks
Category
Other

4

Description
vitamin D3 and calcium placebos for 8 weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Isfahan Endocrine and Metabolism Research Center
Full name of responsible person
Street address
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Isfahan University of Medical Science
Full name of responsible person
Ahmad Esmaillzadeh
Street address
Hezarjerib st. Mdical school of Isfahan,
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Isfahan University of Medical Science
Full name of responsible person
Marjan Tabesh
Position
MSc condidate in Nutrition
Other areas of specialty/work
Street address
Hezarjerib st. medical school of Isfahan
City
Isfahan
Postal code
Phone
+98 913 166 4159
Fax
Email
tabesh@hlth.mui.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Science
Full name of responsible person
Marjan Tabesh
Position
MSc student in Nutrition
Other areas of specialty/work
Street address
Hezarerib st.Medical school of Isfahan
City
Isfahan
Postal code
Phone
+98 913 166 4159
Fax
Email
tabesh@hlth.mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University of Medical Science
Full name of responsible person
Marjan Tabesh
Position
MSc condidate in Nutrition
Other areas of specialty/work
Street address
Isfahan University of medical Science, Hezar jerib St.
City
Isfahan
Postal code
Phone
+98 31 1792 7922
Fax
Email
tabesh@hlth.mui.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
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Study Protocol
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Statistical Analysis Plan
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Informed Consent Form
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Clinical Study Report
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Analytic Code
empty
Data Dictionary
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