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The effect of vitamin D supplementation on anxiety, inflammation, Omentin and Vaspin biomarkers in diabetic women

Protocol summary

Study aim
Determine the effect of vitamin D supplementation on anxiety, inflammation, Omentin and Vaspin biomarkers in diabetic women
Design
After selecting 50 diabetic women according to inclusion and exclusion criteria, they randomly divide to intervention and placebo groups using age blocks, Each participant will be given a code At the beginning and the end of the study, the anxiety score, the levels of omentin and vasipin adipokines, CRP, and IL-10 are compared.
Settings and conduct
The target population of women with diabetes are referred to Shahr-e-kord Diabetes Association. Randomized, double-blind study conducted over 16 weeks. Patient codes are not provided to the patient and the researcher. The similarity of a soft capsule of vitamin D and placebo(Both supplements were produced by Tabriz Zahravi Company) will not endanger blinding.
Participants/Inclusion and exclusion criteria
All participants are women and have diabetes and anxiety and the serum level of 25 hydroxy vitamin D is between 10 and 30 ng per deciliter ؛ Those have severe psychiatric disorders or chronic disease and consume drug for depression, vitamin D or multivitamin supplement and alcohol during the last 4 month and consumption not be enter in this study.
Intervention groups
The intervention group every two weeks receives a soft capsule of 50,000 international units of vitamin D (produced from Zahravi, Tabriz, Iran) for 16 weeks. The control group take placebo (oral paraffin (obtained from Zahravi, Tabriz, Iran) for 16 weeks in parallel to intervention group.
Main outcome variables
Anxiety, stress, depression, omentin and vasipin adipokines, interleukin-10 and CRP

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170927036451N1
Registration date: 2017-12-15, 1396/09/24
Registration timing: retrospective

Last update: 2017-12-15, 1396/09/24
Update count: 0
Registration date
2017-12-15, 1396/09/24
Registrant information
Name
Siavash Fazelian
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36688487
Email address
siavash.fazelian@nutr.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Isfahan University of Medical Sciences
Expected recruitment start date
2017-01-20, 1395/11/01
Expected recruitment end date
2017-10-02, 1396/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of vitamin D supplementation on anxiety, inflammation, Omentin and Vaspin biomarkers in diabetic women
Public title
Effect of vitamin D supplementation on anxiety and inflammation in diabetic women.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Tendency to cooperate with research project Fasting blood higher than 126 milligram per deciliter or a two-hour blood sugar higher than 200 milligram per deciliter Age: 20 to 50 years; serum 25 Hydroxy vitamin D level less than 30 nanogram per milliliter Detection of mild or severe anxiety by the DASS21 questionnaire
Exclusion criteria:
Have not past medical history of attack or stroke; Severe depression in the previous years Taking Orlistat drugs (Venostat, Zenical) and anti-epileptic drugs such as phenobarbital and phenytoin Taking any supplements such as multivitamin and vitamin d during the 4 months prior to the study Smoking , alcohol intake pregnancy or lactation Not wanting to continued cooperation
Age
From 35 years old to 60 years old
Gender
Female
Phase
2-3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
After screening, all eligible diabetic patients are randomly allocated in a 1:1 ratio to vitamin D treatment or to matching placebo by permuted block randomization method according to age block.
Blinding (investigator's opinion)
Double blinded
Blinding description
After explaining the purpose of the study, all participants and investigators including the laboratory staff and Statistical analyzer are blinded to random allocation. Participants in vitamin D group receive vitamin D 50000 IU supplement while control group take placebo with the same size and color as vitamin D soft gels (Oral paraffin) which both supplements are produced by Zahrawi Tabriz Company in Iran.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezarjerib st., Isfahan,Iran.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2016-12-21, 1395/10/01
Ethics committee reference number
ir.mui.rec.1395.3.736

Health conditions studied

1

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

Primary outcomes

1

Description
vaspin hormone serum levels
Timepoint
Before and 16 weeks after the start of intervention
Method of measurement
Blood testing (by ELISA kit)

2

Description
omentin hormone serum levels
Timepoint
Before and 16 weeks after the start of intervention
Method of measurement
Blood testing (by ELISA kit)

3

Description
interleukin-10 serum levels
Timepoint
Before and 16 weeks after the start of intervention
Method of measurement
Blood testing (by ELISA kit)

4

Description
CRP serum levels
Timepoint
Before and 16 weeks after the start of intervention
Method of measurement
Blood testing (by ELISA kit)

5

Description
Anxiety score
Timepoint
Before and 16 weeks after the start of intervention
Method of measurement
by DASS21 questionnaire

6

Description
Depression score
Timepoint
Before and 16 weeks after the start of intervention
Method of measurement
by DASS21 questionnaire

7

Description
Stress score
Timepoint
Before and 16 weeks after the start of intervention
Method of measurement
by DASS21 questionnaire

Secondary outcomes

1

Description
BMI
Timepoint
Before and 16 weeks after the start of intervention
Method of measurement
computing

2

Description
Waist circumference
Timepoint
Before and 16 weeks after the start of intervention
Method of measurement
Strip meter

3

Description
weight
Timepoint
Before and 16 weeks after the start of intervention
Method of measurement
Scales

4

Description
vitamin D serum levels
Timepoint
Before and 16 weeks after the start of intervention
Method of measurement
Blood testing (by ELISA kit)

Intervention groups

1

Description
The intervention group every two weeks receives a soft Vitamin D Placebo Capsule (Oral Paraffin, Tabriz Zahrawi Company) for 16 weeks.
Category
Other

2

Description
The control group consumes a placebo capsule of vitamin D (oral paraffin, Zahravi, Tabriz) every two weeks for 16 weeks .
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Chahar Mahal and Bakhtiari Diabetes Association
Full name of responsible person
Saiavash Fazelian
Street address
Nur Construction , North Twelve Muharram Ave., Shahr-e-kord Town
City
Shahr-e-kord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813769671
Phone
+98 38 3336 7012
Email
siavashfazelian@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research,Isfahan University of Medical Sciences
Full name of responsible person
Dr Alavi
Street address
Vice chancellor for research,Isfahan University of Medical Sciences, Hezar jarib st, Isfahan. Iran
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۶۱
Phone
+98 31 3668 8487
Email
pr_nutr@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research,Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Siavash Fazelian
Position
PhD candidate of Nutrition science
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Faculty of Nutrition and Food Sciences ,Isfahan University of Medical Sciences, Hezar jarib st, Isfahan. Iran
City
Isfahan
Province
Isfehan
Postal code
8813769671
Phone
+98 383367012
Fax
Email
siavash.fazelian@nutr.mui.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr Reza Amani
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Street address
Faculty of Nutrition and Food Sciences ,Isfahan University of Medical Sciences, Hezar jarib st, Isfahan. Iran
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۶۱
Phone
+98 31 3792 3175
Fax
Email
r_amani@mail.mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Siavash Fazelian
Position
PhD candidate of Nutrition science
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Faculty of Nutrition and Food Sciences ,Isfahan University of Medical Sciences, Hezar jarib st, Isfahan. Iran
City
Isfahan
Province
Isfehan
Postal code
8813769671
Phone
+98 313367012
Fax
Email
siavash.fazelian@nutr.mui.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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