Protocol summary

Study aim
Effect of vitamin B1 (thiamine) on blood pressure, lipid profile, liver enzymes, fasting blood sugar, metabolic syndrome patients in military patients referred to 525(khorramabad) Army Hospital
Design
This study was performed as randomized, parallel controlled clinical trial on 116 patients with Mets
Settings and conduct
This study was performed as randomized, parallel controlled clinical trial on 116 patients with Metabolic Syndrome. In this study, while receiving written informed consent from patients, participants were blinded to receiving drugs and placebo.
Participants/Inclusion and exclusion criteria
Age range for the present study 25 to 50 years is considered and accordingly, subjects that aged 25- 50 years, and according to IDF criteria, waist circumference shall be equal to or greater than 94 and 80 cm in men and women, respectively. In addition to waist circumference, if candidates meet two of the following 4 criteria, they will be diagnosed with MetS: Fasting blood sugar above 100 mg / dl  Triglycerides equal to or greater than 150 mg / dL  Blood pressure equal to or greater than 135/85 mm Hg   HDL less than 40 and 50 mg / dl in men and women, respectively No admitance and exclusion criteria from study History of cardiovascular disease Hepatic, renal and metabolic disorders Alcohol , cigarettes, supplements and certain drugs consumption People who during the study less than 80% of the tablets vitamin b1 (thiamin) and placebo to consume
Intervention groups
Participants into two categories consumer vitamin b1 and placebo divided
Main outcome variables
Indicators of profail lipidi(TG-Chol-HDL-LDL) , liver enzymes(ALT- AST), fasting blood suger, blood perser systolic ,blood perser diystolic

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180201038585N5
Registration date: 2019-11-10, 1398/08/19
Registration timing: registered_while_recruiting

Last update: 2019-11-10, 1398/08/19
Update count: 0
Registration date
2019-11-10, 1398/08/19
Registrant information
Name
Karim Parastouei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8248 3516
Email address
parastouei@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-17, 1398/07/25
Expected recruitment end date
2019-12-16, 1398/09/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of vitamin B1 (thiamine) on blood pressure, lipid profile, liver enzymes and fasting blood sugar in patients with metabolic syndrome
Public title
The effect of vitamin B1 (thiamine) on blood pressure, lipid profile, liver enzymes and fasting blood sugar in the military with metabolic syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age: 25 -50 years Military personnel with metabolic syndrome
Exclusion criteria:
Having a history of cardiovascular disease morbility liver, kidney Consumption alcoho, smoking ,supplementation and certain drugs People who during the study less than 80% of the tablets vitamin b1 and placebo to consume.
Age
From 25 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 116
Randomization (investigator's opinion)
Randomized
Randomization description
A simple dice randomization method was used in which paired numbers for the intervention group and individual numbers for the control group were used.
Blinding (investigator's opinion)
Double blinded
Blinding description
Intervention and randomization were performed through a random allocation list by a member of the research team as the only blinded individual to the assignment. Other members of the research team (including team leader and study coordinator), as well as all participants, were randomly assigned to groups and intervention and remained blind until the end of the study.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of bahgeyatlah University of Medical Sciences
Street address
Moulla Sadra Ave , Vannak Square
City
Tehran
Province
Tehran
Postal code
1435916471
Approval date
2019-08-27, 1398/06/05
Ethics committee reference number
IR.BMSU.REC.1398.240

Health conditions studied

1

Description of health condition studied
Metabolic syndrome
ICD-10 code
E00-E90
ICD-10 code description
Endocrine, nutritional and metabolic diseases

Primary outcomes

1

Description
fasting blood sugar
Timepoint
before intervention and end of intervention
Method of measurement
Lab kit

2

Description
Triglyceride
Timepoint
before intervention and end of intervention
Method of measurement
Lab kit

3

Description
cholesterol
Timepoint
before intervention and end of intervention
Method of measurement
Lab kit

4

Description
blood presure
Timepoint
before intervention and end of intervention
Method of measurement
Lab kit

5

Description
Alanin transfrase
Timepoint
before intervention and end of intervention
Method of measurement
Lab kit

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Vitamin B1, 100 mg, every day, darou pakhsh
Category
Treatment - Drugs

2

Description
Control group: Placebo
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Khorramabad Army Hospital
Full name of responsible person
Yaser Souri
Street address
5 km of Khorramabad-Andimeshk Highway
City
Khorramabad
Province
Lorestan
Postal code
6812345678
Phone
+98 66 3347 0525
Email
arvin.souri@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Ali Shiri
Street address
Mollasadra Ave, Vanak Sq, Tehran
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8248 3516
Email
arvin.souri@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah 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
Bagheiat-allah University of Medical Sciences
Full name of responsible person
karim Parastouei
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Mullasadra Ave, Vannak Sq,Tehran
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8248 3264
Email
karimparastouei@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Karim Parastouei
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Mullasadra Ave, Vannak Sq, Tehran
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
981435916471
Email
Karimparastouei@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Karim Parastouei
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Mullasadra Ave, Vannak Sq, Tehran
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8248 3264
Email
Karimparastouei@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Because of the confidentiality of the information on the civilians
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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