Protocol summary

Summary
This study is a single blind placebo- control clinical trial that will be done to aim of comparative study of the effect of fortified yogurt with vitamin D, plain yogurt and vitamin D supplement on Glycemic, lipid and anthropometric indices in patients referred to Taleghani Hospital Diabetic Clinic that recently they have been diagnosed with pre-diabetes condition. Sampling will be done the based on inclusion criteria and available sampling, then samples place randomly in three interventions, including fortified yogurt (100cc/day) with 1000 IU Vitamin D receiving group, vitamin D supplement (1000 IU/day) receiving group, plain yoghurt (100cc/day) receiving group. Inclusion criteria, including full consent of the individual, 25-65 years old, not family history of diabetes, lack of other chronic diseases (coronary heart, liver, kidney, thyroid, parathyroid, malabsorption, ...) or special circumstances such as pregnancy and breastfeeding, avoiding the use of any supplements or drugs and no smoking. Exclusion criteria, including lack of interest in the continuation of cooperation, failure to follow the consumption of specified amount of fortified yogurt with vitamin D, plain yogurt and vitamin D supplement and require to use of oral anti diabetic drug. The Intervention will be done for three months, before and three months after intervention are evaluated glycemic, lipids and anthropometric indices. To collect the data will use of questionnaires, including demographic data and disease status, physical activity and food frequency questionnaire (FFQ). Also to collect anthropometric data will use of Body composition Analyzer .In order to investigation of the blood indices, including fasting blood glucose, HbA1c, 2h- OGTT, fasting insulin, vitamin D, ca, AST, ALT, TC, LDL-c, HDL-c and TG, will be take 10 cc of blood in the fasting state, before and three month after the intervention. The study is in the recruitment phase. Blinding will be done to Analysts of data.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016102615111N2
Registration date: 2017-02-24, 1395/12/06
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-02-24, 1395/12/06
Registrant information
Name
Seyyed Mostafa Nachvak
Name of organization / entity
kermanshah university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1826 2005
Email address
m.nachrak@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah university of medical sciences Damdaran company of Dairy
Expected recruitment start date
2016-10-22, 1395/08/01
Expected recruitment end date
2016-11-21, 1395/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparative study of the effect of fortified yogurt with vitamin D, plain yogurt and vitamin D supplement on Glycemic, lipid and anthropometric indices in people with pre-diabetes
Public title
The effect of vitamin D on prevention of Diabetes
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria : Full consent of the individual, 25-65 years old, not family history of diabetes, lack of other chronic diseases (coronary heart, liver, kidney, thyroid, parathyroid, malabsorption, ...) or special circumstances such as pregnancy and breastfeeding, avoiding the use of any supplements or drugs and no smoking. Exclusion criteria :lack of interest in the continuation of cooperation, failure to follow the consumption of specified amount of fortified yogurt with vitamin D, plain yogurt and vitamin D supplement and require to use of oral anti diabetic drug.
Age
From 25 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
In This study receiving groups of fortified yogurt and plain yogurt and researchers will be blind about nature of yogurts. The random placement of subjects in intervention groups is based on the random numbers table.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Kermanshah University of Medical Sciences
Street address
Ethics Committee, Building No. 2 of Kermanshah University of Medical Sciences, Naft Square, Shahid Beheshti blvd
City
Kermanshah
Postal code
Approval date
2016-10-19, 1395/07/28
Ethics committee reference number
KUMS.REC.1395.447

Health conditions studied

1

Description of health condition studied
Prediabetes
ICD-10 code
E10, E11,
ICD-10 code description
Diabetes mellitus

Primary outcomes

1

Description
HbA1c
Timepoint
Befor and 3 month after of intervention
Method of measurement
Pishtazteb HbA1c Kit

2

Description
2h-OGTT
Timepoint
Befor and 3 month after of intervention
Method of measurement
Pars azmon OGTT Kit

3

Description
Vitamin D
Timepoint
Befor and 3 month after of intervention
Method of measurement
Vitamin D MONOBIND Kit

4

Description
Ca
Timepoint
Befor and 3 month after of intervention
Method of measurement
Pars azmon Calcium Kit

5

Description
Serum insulin
Timepoint
Befor and 3 month after of intervention
Method of measurement
Insulin MONOBIND Kit

6

Description
FBS
Timepoint
Befor and 3 month after of intervention
Method of measurement
Pars azmon glucose kit

7

Description
T-chol
Timepoint
Befor and 3 month after of intervention
Method of measurement
Pars azmon Cholesterol Kit

8

Description
LDL-c
Timepoint
Befor and 3 month after of intervention
Method of measurement
Pars azmon LDL- c Kit

9

Description
HDL-c
Timepoint
Befor and 3 month after of intervention
Method of measurement
Pars azmon HDL- c Kit

10

Description
TG
Timepoint
Befor and 3 month after of intervention
Method of measurement
Pars azmon Triglyceride Kit

11

Description
ALT
Timepoint
Befor and 3 month after of intervention
Method of measurement
Pars azmon ALT Kit

12

Description
AST
Timepoint
Befor and 3 month after of intervention
Method of measurement
Pars azmon AST Kit

Secondary outcomes

1

Description
FBS
Timepoint
Befor and 3 month after of intervention
Method of measurement
Pars azmon glucose kit

2

Description
Serum insulin
Timepoint
Befor and 3 month after of intervention
Method of measurement
Insulin MONOBIND Kit

3

Description
TG
Timepoint
Befor and 3 month after of intervention
Method of measurement
Pars azmon Triglyceride Kit

4

Description
vitamin D
Timepoint
Befor and 3 month after of intervention
Method of measurement
Vitamin D MONOBIND Kit

5

Description
Ca
Timepoint
Befor and 3 month after of intervention
Method of measurement
Pars azmon Calcium Kit

6

Description
HbA1c
Timepoint
Befor and 3 month after of intervention
Method of measurement
Pishtazteb HbA1c Kit

7

Description
T-chol
Timepoint
Befor and 3 month after of intervention
Method of measurement
Pars azmon Cholesterol Kit

8

Description
LDL-c
Timepoint
Befor and 3 month after of intervention
Method of measurement
Pars azmon LDL- c Kit

9

Description
HDL-c
Timepoint
Befor and 3 month after of intervention
Method of measurement
Pars azmon HDL- c Kit

10

Description
2h-OGTT
Timepoint
Befor and 3 month after of intervention
Method of measurement
Pars azmon OGTT Kit

11

Description
ALT
Timepoint
Befor and 3 month after of intervention
Method of measurement
Pars azmon ALT Kit

12

Description
AST
Timepoint
Befor and 3 month after of intervention
Method of measurement
Pars azmon AST Kit

Intervention groups

1

Description
Riched yogurt (100cc/day) with 1000 IU Vitamin D reciving group Intervention Duration: 3 month
Category
Prevention

2

Description
vitamin D supplement (1000 IU/day) receiving group
Category
Prevention

3

Description
plain yoghurt (100cc/day) reciving group
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Headari
Street address
Taleghani Hospital, Naft Square, Shahid Beheshti blvd
City
Kermanshah

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research, Kermanshah University of Medical Sciences
Full name of responsible person
Heidarian
Street address
Vice Chancellor for research, Building No. 2 of Kermanshah University of Medical Sciences, Naft Square, Shahid Beheshti blvd
City
Kermanshah
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, Kermanshah University of Medical Sciences
Proportion provided by this source
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

2

Sponsor
Name of organization / entity
Damdaran Company of Dairy
Full name of responsible person
Tabatabaei
Street address
Damdaran Company of Dairy, Damdaran blvd, Haft joy industrial rural districtn, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Damdaran Company of Dairy
Proportion provided by this source
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
Public Health faculty
Full name of responsible person
Roghayeh Mostafai
Position
MSC Student
Other areas of specialty/work
Street address
Public Health faculty, Next to the Farabi Hospital, Dolat Abad blvd, Isar Square, Imam Hosein Exp
City
kermanshah
Postal code
6719851351
Phone
+98 83 3827 6394
Fax
Email
r_mostafai@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty of Health
Full name of responsible person
Seyed Mostafa Nachvak
Position
PHD
Other areas of specialty/work
Street address
Public Health faculty, Next to the Farabi Hospital, Dolat Abad blvd, Isar Square, Imam Hosein Exp
City
kermanshah
Postal code
6719851351
Phone
+98 83 3826 2052
Fax
Email
Smnachvak@hotmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Public Health faculty
Full name of responsible person
Roghayeh Mostafai
Position
MSC student
Other areas of specialty/work
Street address
Public Health faculty, Next to the Farabi Hospital, Dolat Abad blvd, Isar Square, Imam Hosein Exp
City
Kermanshah
Postal code
6719851351
Phone
+98 83 3827 6394
Fax
Email
r_mostafai@yahoo.com
Web page address

Sharing plan

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